Efficacy and Safety of Insulin Glargine 300 U/mL versus 100 U/mL in Diabetes Mellitus: A Comprehensive Review of the Literature.

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Insulin 4 endocrinologydiseasesdrugs
diabetic ketoacidosis 3 endocrinologydiseases
diabetic retinopathy 10 endocrinologydiseases
type 1 diabetes mellitus 2 endocrinologydiseases
metformin 2 endocrinologydiseasesdrugs
obesity 1 endocrinologydiseases
type 2 diabetes mellitus 3 endocrinologydiseases
Insulin Glargine 1 endocrinologydiseasesdrugs
diabetes mellitus 7 endocrinologydiseases
hyperglycemia 3 endocrinologydiseases
hypoglycemia 203 endocrinologydiseases

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Insulin 58 Title: Journal of Diabetes ResearchEfficacy and Safety of Insulin Glargine 300 U/mL versus 100 U/mL in Diabetes Mellitus: A Comprehensive Review of the LiteratureHernando
Insulin 680 necessary. The need for insulin depends upon the balance between insulin secretion and insulin resistance. Insulin is considered the most effective glucose-lowering therapy available and is required by people with type
Insulin 3666 insulin in some patients. The number of patients requiring insulin is expected to rise more steeply. Insulin may be the desired therapy in individuals with T2DM with critical beta-cell failure and intolerance
Insulin 4980 published in English were included.3. General Considerations about the Clinical Results with Analogue Basal Insulin sLong-acting insulin analogues such as glargine (Glar), detemir (Det), and degludec (Deg) were developed
Insulin Glargine 58 Title: Journal of Diabetes ResearchEfficacy and Safety of Insulin Glargine 300 U/mL versus 100 U/mL in Diabetes Mellitus: A Comprehensive Review of the LiteratureHernando
metformin 14394 Glar-100 or NPH, together with mealtime therapy with insulin lispro, aspart, or glulisine, with or without metformin , for at least 1 year. The exclusion criteria were as follows: age < 18 years; HbA1c < 7.0% or
metformin 132128 (%)Glar-300Glar-100Glar-300Glar-100Glar-300Glar-100Glar-300 (N/A)Glar-100 (N/A)Glar-300 (N/A)Glar-100 (N/A)Glar-300Glar-100Prior use of metformin 56.258.694.893.690.692.057.959.2Prior use of SU0.20.02.00.559.158.652.955Prior use of DPP-4 inh.0.00.07.712.520.722.442.144.2Prior
Select Disease Character Offset Disease Term Instance
diabetes mellitus 794 considered the most effective glucose-lowering therapy available and is required by people with type 1 diabetes mellitus to control their blood glucose levels; yet, many people with type 2 diabetes mellitus will also eventually
diabetes mellitus 880 people with type 1 diabetes mellitus to control their blood glucose levels; yet, many people with type 2 diabetes mellitus will also eventually require insulin therapy, due to the progressive nature of the disease. A variety
diabetes mellitus 1749 glargine-300 versus glargine-100 from the EDITION clinical trial program, in patients with type 1 and type 2 diabetes mellitus .1. IntroductionThe frequency of diabetes mellitus (DM) has increased worldwide, leading to a huge social,
diabetes mellitus 1799 trial program, in patients with type 1 and type 2 diabetes mellitus.1. IntroductionThe frequency of diabetes mellitus (DM) has increased worldwide, leading to a huge social, economic, and healthcare burden. DM is considered
diabetes mellitus 133673 (mg/dL)185.7188.1198.3195.2196.9202.3177.6186.3177.6178.6176.8178.1α-glucosidase inh.: alpha-glucosidase inhibitors; BMI: body mass index; DM: diabetes mellitus ; DPP-4 inh.: inhibitors of dipeptidyl peptidase 4; EC: exclusion criteria; FPG: fasting plasma glucose;
diabetes mellitus 138231 baseline; Glar-100: insulin glargine 100 U/mL; Glar-300: insulin glargine 300 U/mL; T1DM: type 1 diabetes mellitus ; T2DM: type 2 diabetes mellitus; W8: week 8; W9: week 9.Table 4Proportion of patients with TEAEs, drop-out
diabetes mellitus 138263 glargine 100 U/mL; Glar-300: insulin glargine 300 U/mL; T1DM: type 1 diabetes mellitus; T2DM: type 2 diabetes mellitus ; W8: week 8; W9: week 9.Table 4Proportion of patients with TEAEs, drop-out rates, and rescue therapy
diabetic ketoacidosis 23111 in the morning or evening; severe hypoglycemia resulting in coma/seizures and/or hospitalization for diabetic ketoacidosis in the last 6 mo before the screening visit; or unstable proliferative diabetic retinopathy or any
diabetic ketoacidosis 25372 pump in the next 12 mo; severe hypoglycemia resulting in coma/seizures and/or hospitalization for diabetic ketoacidosis in the last 6 mo before the screening visit; or unstable proliferative diabetic retinopathy or any
diabetic ketoacidosis 27167 before the screening visit; severe hypoglycemia resulting in coma/seizures and/or hospitalization for diabetic ketoacidosis in the last 6 mo before the screening visit; or unstable proliferative diabetic retinopathy or any
diabetic retinopathy 15007 weight loss drugs in the last 3 mo before the screening visit; history or presence of significant diabetic retinopathy or macular edema likely to require laser, injectable drugs, or surgical treatment during the study period;
diabetic retinopathy 17711 treatments; use of an insulin pump in the last 6 mo before screening; history or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study
diabetic retinopathy 20388 (e.g., acute illness and surgery) during the last year prior to screening; and unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment during
diabetic retinopathy 20442 prior to screening; and unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment during the study period. Participants receiving only noninsulin
diabetic retinopathy 23206 for diabetic ketoacidosis in the last 6 mo before the screening visit; or unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (e.g.,
diabetic retinopathy 23260 the screening visit; or unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (e.g., laser, surgical treatment, or injectable drugs)
diabetic retinopathy 25467 for diabetic ketoacidosis in the last 6 mo before the screening visit; or unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment during
diabetic retinopathy 25521 the screening visit; or unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment during the study period [[53], [54]].5.6. EDITION JP2 TrialThe
diabetic retinopathy 27262 for diabetic ketoacidosis in the last 6 mo before the screening visit; or unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment during
diabetic retinopathy 27316 the screening visit; or unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment during the study period.Following a 6 mo treatment period,
hyperglycemia 2794 people, or 1 adult in every 10, will have diabetes [[3], [4]].DM is a chronic disease characterized by hyperglycemia from defects in insulin secretion, insulin action, or both. Type 1 (T1) DM usually begins at a young
hyperglycemia 15997 (DTSQ). The DTSQ addresses the participant's satisfaction with the treatment (six items), perceived hyperglycemia (one item), and perceived hypoglycemia (one item), as well as the change from BL in body weight, percentage
hyperglycemia 23945 participant-reported satisfaction with the treatment and perception of the occurrence of hypo- and hyperglycemia [using the DTSQ, health-related quality of life (EQ-5D) utility index score, and hypoglycemia fear survey
hypoglycemia 5357 clinical use of neutral protamine Hagedorn (NPH) insulin (i.e., absorption variability and risk of hypoglycemia ). Considerable progress has been made in terms of pharmacokinetics (PKs) and pharmacodynamics (PDs),
hypoglycemia 5550 pharmacodynamics (PDs), including longer action, sustained glucose-lowering effect (with lower risk of hypoglycemia ), low intraindividual variability, and potential higher flexibility of the administration regimes [[11],
hypoglycemia 6011 plasma glucose (FPG), regardless of the OAD-based management, with lower rates of global and nocturnal hypoglycemia in the Glar-100-treated patients. Furthermore, there was a slight increase in the total daily dose of
hypoglycemia 6425 Glar-100 resulted in a mild but significant decrease in the level of HbA1c, with less episodes of severe hypoglycemia and nocturnal hypoglycemia, as compared to NPH management [[15]–[17]].Moreover, clinical trials comparing
hypoglycemia 6452 significant decrease in the level of HbA1c, with less episodes of severe hypoglycemia and nocturnal hypoglycemia , as compared to NPH management [[15]–[17]].Moreover, clinical trials comparing Det insulin and NPH
hypoglycemia 6817 a higher proportion of individuals achieved the HbA1c < 7% goal, with lower rates of confirmed hypoglycemia with Det. Patients managed with Det also experienced less weight gain compared to patients receiving
hypoglycemia 7104 Det treatment significantly lowered the HbA1c levels and FPG, with less weight gain and lower risk of hypoglycemia , as compared to NPH management. However, subjects in the Det group required a higher average daily dose
hypoglycemia 7598 HbA1c or FPG levels, or in the proportion of patients achieving the HbA1c goal without symptomatic hypoglycemia . Furthermore, a small but significant weight gain was documented in the population treated with Glar-100;
hypoglycemia 8245 values or the proportion of individuals achieving the HbA1c < 7% goal in the absence of confirmed hypoglycemia , although self-measured FPG levels were significantly lower with Glar-100 than with Det. No significant
hypoglycemia 8722 management provides glycemic control similar to that achieved with Glar-100, with lower risk of nocturnal hypoglycemia and overall hypoglycemia in T2DM patients using the basal-bolus regime. By contrast, in patients treated
hypoglycemia 8747 control similar to that achieved with Glar-100, with lower risk of nocturnal hypoglycemia and overall hypoglycemia in T2DM patients using the basal-bolus regime. By contrast, in patients treated with basal regimes combined
hypoglycemia 8938 treated with basal regimes combined with OADs, the use of Deg was associated with lower risk of nocturnal hypoglycemia or severe hypoglycemia, as compared with that of Glar-100. Additionally, the rates of treatment-emergent
hypoglycemia 8961 combined with OADs, the use of Deg was associated with lower risk of nocturnal hypoglycemia or severe hypoglycemia , as compared with that of Glar-100. Additionally, the rates of treatment-emergent adverse events (AEs)
hypoglycemia 9473 trials showed that, among patients with T1DM and in T2DM treated with insulin (and with at least one hypoglycemia risk factor), the Deg treatment resulted in a reduced rate of overall symptomatic hypoglycemia, as compared
hypoglycemia 9568 one hypoglycemia risk factor), the Deg treatment resulted in a reduced rate of overall symptomatic hypoglycemia , as compared to Glar-100 [[34], [35]].4. General Observations about GLAR-300Glar-300 was developed to
hypoglycemia 11108 peak of action could theoretically result in a more gradual reduction in BG, with a reduced risk of hypoglycemia , while achieving glycemic control. Finally, the potency of Glar-300 is stated in units; these units
hypoglycemia 12394 primary and secondary efficacy variables and safety variables, such as the definitions used for the hypoglycemia categories and analyses [[39]]. Additionally, patients already on Glar-100 prior to the study were switched
hypoglycemia 15492 trial, the authors examined whether the pattern of glycemic control, tolerability, and risk of nocturnal hypoglycemia was achieved with continued use of Glar-300 for a further 6 mo interval of randomized but less intensively
hypoglycemia 16037 participant's satisfaction with the treatment (six items), perceived hyperglycemia (one item), and perceived hypoglycemia (one item), as well as the change from BL in body weight, percentage of participants experiencing ≥1
hypoglycemia 21127 SMPG, 8-point SMPG profiles, and basal insulin dose. Safety/tolerability outcomes included risk of hypoglycemia , change from BL to month 12 in body weight, and the occurrence of other AEs. An additional post hoc
hypoglycemia 21539 assessed, defined as the percentage of participants achieving HbA1c target (<7.0%) at month 12 without hypoglycemia (confirmed or severe or documented symptomatic) at night and at any time of the day (24 h) over 12 mo
hypoglycemia 23044 insulin Glar as assigned by the randomization process once daily in the morning or evening; severe hypoglycemia resulting in coma/seizures and/or hospitalization for diabetic ketoacidosis in the last 6 mo before
hypoglycemia 24040 and hyperglycemia [using the DTSQ, health-related quality of life (EQ-5D) utility index score, and hypoglycemia fear survey (HFS II)] [[51], [52]].5.5. EDITION JP1 TrialThe EDITION JP1 was a 6 mo, multicenter,
hypoglycemia 25305 6 mo before the screening visit and/or plan to switch to an insulin pump in the next 12 mo; severe hypoglycemia resulting in coma/seizures and/or hospitalization for diabetic ketoacidosis in the last 6 mo before
hypoglycemia 27100 glucose-lowering medications and/or weight loss drugs in the last 3 mo before the screening visit; severe hypoglycemia resulting in coma/seizures and/or hospitalization for diabetic ketoacidosis in the last 6 mo before
hypoglycemia 28149 endpoints were Percentage of participants with hypoglycemic events [and the annualized event rates for hypoglycemia (events per participant-year), by a study period] and the cumulative mean number of hypoglycemic events
hypoglycemia 28559 nocturnal, 00:00–05:59 h)]. The EDITION trials comprised three follow-up periods for the evaluation of hypoglycemia : titration phase (BL to week 8), maintenance phase (week 9 to month 6; this follow-up period was established
hypoglycemia 28750 follow-up period was established to avoid the possibility of any temporary disruptions in the risk of hypoglycemia that could arise when switching from Glar-100, usually to Glar-300), and throughout the follow-up (BL
hypoglycemia 29615 collection of a number of common data for reference purposes. This trial also assessed fear to develop hypoglycemia using the HSF-II score, which is a survey that evaluates different aspects associated with the fear
hypoglycemia 29739 HSF-II score, which is a survey that evaluates different aspects associated with the fear to present hypoglycemia under various circumstances [[57]–[60]].5.8. MethodsThe EDITION studies tested the main hypothesis
hypoglycemia 32377 period (from 23.00–7.00 h to 00.00–05.59 h) in all phase 3 studies was adjusted. Nocturnal hypoglycemia was defined by this time period whether the patient was awake or asleep. The reason for the time adjustment
hypoglycemia 44176 target of <7.0% without nocturnal (00:00–05:59 h) confirmed [≤3.9 mmol/L (70 mg/dL)] or severe hypoglycemia was 23% for Glar-300 and 19% for Glar-100 [responder ratio: 1.24 (95% CI: 0.96 to 1.61)]. For those
hypoglycemia 44346 ratio: 1.24 (95% CI: 0.96 to 1.61)]. For those without nocturnal documented symptomatic (≤70 mg/dL) hypoglycemia , the percentage of participants was 28% versus 24% (responder ratio: 1.19; 95% CI: 0.96 to 1.49).The
hypoglycemia 59816 participants in the EDITION clinical trial program are shown in Table 2.5.10. HypoglycemiaThe risk of hypoglycemia was lower in subjects receiving Glar-300 treatment. For instance, in the EDITION 1 trial, the reduction
hypoglycemia 59954 receiving Glar-300 treatment. For instance, in the EDITION 1 trial, the reduction in risk of nocturnal hypoglycemia (≤70 mg/dL) was 21% on average (and 16% at month 12). In terms of the definition of at-any-time
hypoglycemia 60067 (≤70 mg/dL) was 21% on average (and 16% at month 12). In terms of the definition of at-any-time hypoglycemia (≤70 mg/dL), the reduction was 14%, 7%, and 6% for the BL to week 8, BL to month 6, and BL to month
hypoglycemia 60472 month 6 was 36% for Glar-300 versus 46% for Glar-100; the analysis of this prespecified main measure of hypoglycemia demonstrated superiority of Glar-300 over Glar-100 [relative risk (RR): 0.79; 95% CI: 0.67 to 0.93;
hypoglycemia 60646 risk (RR): 0.79; 95% CI: 0.67 to 0.93; P = 0.0045]. The percentage of participants reporting severe hypoglycemia at any time of the day or night (24 h) was 5.0% for Glar-300 versus 5.7% for Glar-100 (RR: 0.87; 95%
hypoglycemia 60960 for meaningful analysis, the percentage of participants within each category of nocturnal events [any hypoglycemia : documented (≤70 and <54 mg/dL) symptomatic hypoglycemia and confirmed (≤70 and <54 mg/dL) or
hypoglycemia 61021 each category of nocturnal events [any hypoglycemia: documented (≤70 and <54 mg/dL) symptomatic hypoglycemia and confirmed (≤70 and <54 mg/dL) or severe hypoglycemia] was lower for Glar-300 than for Glar-100
hypoglycemia 61082 documented (≤70 and <54 mg/dL) symptomatic hypoglycemia and confirmed (≤70 and <54 mg/dL) or severe hypoglycemia ] was lower for Glar-300 than for Glar-100 (RR: 0.72–0.78) throughout the course of treatment. The
hypoglycemia 61302 annualized rates for nocturnal events were lower with Glar-300 (RR: 0.60 to 0.78) across all categories of hypoglycemia other than severe events. The risks of at-any-time events, nocturnal and daytime together, were equivalent
hypoglycemia 61852 ratio: 1.06; 95% CI: 0.89 to 1.27). Annualized rates of nocturnal confirmed (≤70 mg/dL) or severe hypoglycemia did not differ significantly between treatments (2.88 versus 3.19 events per participant-year; rate
hypoglycemia 62025 3.19 events per participant-year; rate ratio: 0.90; 95% CI: 0.70 to 1.16). When the more stringent hypoglycemia threshold (<54 mg/dL) was applied to the categories of documented symptomatic and confirmed or severe
hypoglycemia 62142 threshold (<54 mg/dL) was applied to the categories of documented symptomatic and confirmed or severe hypoglycemia , no significant between-treatment differences were seen. Severe hypoglycemia (any time of the day) was
hypoglycemia 62219 and confirmed or severe hypoglycemia, no significant between-treatment differences were seen. Severe hypoglycemia (any time of the day) was reported by 6.7% of Glar-300-treated and 7.5% of Glar-100-treated participants
hypoglycemia 62444 [46]].Likewise, the EDITION 2 trial showed a similar pattern for the reduction in risk of nocturnal hypoglycemia (≤70 mg/dL), with 47% lower risk over the BL to week 8 period, 23% lower risk over the week 9 to
hypoglycemia 62670 period, and 29% lower risk over the BL to month 6 period. The risk reduction in the at-any-time risk of hypoglycemia in the EDITION 2 trial was statistically significant for the BL to week 8 and BL to month 6 periods
hypoglycemia 62914 reduction of 22% and 10%, resp.). Furthermore, a risk reduction in the documented symptomatic at-any-time hypoglycemia < 54 mg/dL was identified (23% drop) over the BL to month 6 period. During the 6 mo of treatment,
hypoglycemia 63649 CI: 0.61 to 0.99; P = 0.038). The annualized rates of nocturnal confirmed (≤70 mg/dL) or severe hypoglycemia were 1.89 for Glar-300 and 3.68 for Glar-100 (RR: 0.52; 95% CI: 0.35 to 0.77; P = 0.0010). When assessed
hypoglycemia 63895 of HbA1c at the endpoint, the number of events per participant-year of nocturnal confirmed or severe hypoglycemia from week 9 to month 6 was lower in the Glar-300 group than in the Glar-100 group (P = 0.010). The annualized
hypoglycemia 64053 Glar-300 group than in the Glar-100 group (P = 0.010). The annualized event rate for confirmed or severe hypoglycemia was statistically significantly lower for Glar-300 versus Glar-100 at 6 mo (14.01 versus 18.14, RR:
hypoglycemia 64496 with Glar-100 (1.74 versus 2.77, rate ratio: 0.63; 95% CI: 0.42 to 0.96; P = 0.0308). Considering all hypoglycemia , there were fewer nocturnal hypoglycemic events reported with Glar-300 (1.8 events per participant-year)
hypoglycemia 64746 participant-year) (rate ratio: 0.61; 95% CI: 0.41 to 0.92). During the 12 mo study period, severe hypoglycemia at any time was reported by 7 (1.7%) participants (10 events) in the Glar-300 group and 6 (1.5%) participants
hypoglycemia 65202 participants (0.5%) for Glar-100] [[47], [48]].On the other hand, a 24% reduction in the risk of nocturnal hypoglycemia (≤70 mg/dL) over the BL to month 6 period was observed in the EDITION 3 trial, with no benefits
hypoglycemia 65353 period was observed in the EDITION 3 trial, with no benefits identified in the risk of at-any-time hypoglycemia . However, a reduced risk of documented symptomatic hypoglycemia < 54 mg/dL of 49% and 45% (nocturnal
hypoglycemia 65417 identified in the risk of at-any-time hypoglycemia. However, a reduced risk of documented symptomatic hypoglycemia < 54 mg/dL of 49% and 45% (nocturnal and at any time, resp.) was observed over the BL to month
hypoglycemia 65671 BL to month 12 of the EDITION 3 trial, only a benefit in a risk reduction in documented symptomatic hypoglycemia < 54 mg/dL (at any time) was documented.The annualized event rates of nocturnal confirmed or severe
hypoglycemia 65790 hypoglycemia < 54 mg/dL (at any time) was documented.The annualized event rates of nocturnal confirmed or severe hypoglycemia were similar in the two treatment groups during the 6 mo study period; the annualized event rate of
hypoglycemia 65905 were similar in the two treatment groups during the 6 mo study period; the annualized event rate of hypoglycemia at any time was significantly lower with Glar-300 versus Glar-100 over 6 months (6.4 versus 8.5 events
hypoglycemia 66356 percentage of participants experiencing and annualized rates of documented symptomatic (≤70 mg/dL) hypoglycemia at any time, results favored Glar-300 during all predefined study periods (RR: 0.42 to 0.85), with significant
hypoglycemia 66909 more stringent glycemic threshold. A 39% lower risk was observed for confirmed (<54 mg/dL) or severe hypoglycemia (RR: 0.61; 95% CI: 0.43 to 0.87) and a 45% lower risk for documented (<54 mg/dL) symptomatic hypoglycemia
hypoglycemia 67017 hypoglycemia (RR: 0.61; 95% CI: 0.43 to 0.87) and a 45% lower risk for documented (<54 mg/dL) symptomatic hypoglycemia (RR: 0.55; 95% CI: 0.37 to 0.82) over the 6 mo period. Finally, severe hypoglycemia was infrequent,
hypoglycemia 67103 (<54 mg/dL) symptomatic hypoglycemia (RR: 0.55; 95% CI: 0.37 to 0.82) over the 6 mo period. Finally, severe hypoglycemia was infrequent, and events were too few for meaningful analysis. Only 4 participants (1%) in each treatment
hypoglycemia 67246 were too few for meaningful analysis. Only 4 participants (1%) in each treatment group reported severe hypoglycemia at any time.At month 12, the annualized rates of nocturnal confirmed or severe hypoglycemic events were
hypoglycemia 68343 Glar-100 (RR: 0.73; 95% CI: 0.54 to 0.99) [[49], [50]].A significant reduction in the risk of nocturnal hypoglycemia (≤70 mg/dL) was documented in the EDITION 4 trial (−18%) over the BL to week 8 period, but no
hypoglycemia 68526 the BL to week 8 period, but no differences were found between Glar-300 and Glar-100 when the risk of hypoglycemia according to the time of administration of basal insulin was analyzed (morning or evening). The incidence
hypoglycemia 68723 evening). The incidence rates were 78.4 (for Glar-300) and 72.5 events/person-year (for Glar-100) for hypoglycemia (at any time of the day) and 8.0 (for Glar-300) and 9.0 events/person-year (for Glar-100) for nocturnal
hypoglycemia 68840 any time of the day) and 8.0 (for Glar-300) and 9.0 events/person-year (for Glar-100) for nocturnal hypoglycemia . In the preplanned analysis by the study period, the rate ratio for Glar-300 versus Glar-100 in the
hypoglycemia 69045 in the first 8 wk (using the definition of ≤70 mg/dL) was 0.69 (95% CI: 0.53 to 0.91).Severe hypoglycemia was reported by 18 people (6.6%) in the Glar-300 group and by 26 (9.5%) in the Glar-100 group; of these,
hypoglycemia 69473 the night for Glar-300 versus Glar-100, resp.). When analyzed by morning or evening injection time, hypoglycemia in the Glar-300 group did not differ. Over 12 mo, 260 participants (in both treatment groups) had
hypoglycemia 69879 had ≥1 nocturnal event [RR: 0.97 (95% CI: 0.88 to 1.08)].Annualized rates of confirmed or severe hypoglycemia at any time of the day (24 h) were 75.9 and 68.8 events/person-year for Glar-300 and Glar-100, respectively
hypoglycemia 70151 and 8.6 events/person-year at night [rate ratio: 0.95 (95% CI: 0.75 to 1.20)]. The event rates for hypoglycemia over 12 mo were not statistically significant between Glar-300 and Glar-100 for all categories of
hypoglycemia 70279 were not statistically significant between Glar-300 and Glar-100 for all categories of definitions of hypoglycemia (at any time, nocturnal, threshold of ≤70 mg/dL or <54 mg/dL, confirmed or severe hypoglycemia,
hypoglycemia 70380 hypoglycemia (at any time, nocturnal, threshold of ≤70 mg/dL or <54 mg/dL, confirmed or severe hypoglycemia , documented symptomatic hypoglycemia, and severe hypoglycemia) [[51], [52]].Furthermore, in the EDITION
hypoglycemia 70417 threshold of ≤70 mg/dL or <54 mg/dL, confirmed or severe hypoglycemia, documented symptomatic hypoglycemia , and severe hypoglycemia) [[51], [52]].Furthermore, in the EDITION JP1 trial, a reduction in the risk
hypoglycemia 70442 ≤70 mg/dL or <54 mg/dL, confirmed or severe hypoglycemia, documented symptomatic hypoglycemia, and severe hypoglycemia ) [[51], [52]].Furthermore, in the EDITION JP1 trial, a reduction in the risk of nocturnal hypoglycemia
hypoglycemia 70545 hypoglycemia) [[51], [52]].Furthermore, in the EDITION JP1 trial, a reduction in the risk of nocturnal hypoglycemia (≤70 mg/dL) was identified to be 29% and 15% over the BL to week 8 and BL to month 6 periods, respectively;
hypoglycemia 70716 BL to week 8 and BL to month 6 periods, respectively; likewise, in terms of the risk of at-any-time hypoglycemia over the BL to week 8 period (9% reduction), in accordance with the definition of documented symptomatic
hypoglycemia 70834 the BL to week 8 period (9% reduction), in accordance with the definition of documented symptomatic hypoglycemia (nocturnal, <54 mg/dL), the EDITION JP1 trial showed a risk reduction of 36% over the BL to month
hypoglycemia 71494 events (events per participant-year) was lower with Glar-300 for confirmed (≤70 mg/dL) or severe hypoglycemia (at any time) (RR: 0.86; 95% CI: 0.71 to 1.04) and for confirmed (<54 mg/dL) or severe hypoglycemia
hypoglycemia 71596 hypoglycemia (at any time) (RR: 0.86; 95% CI: 0.71 to 1.04) and for confirmed (<54 mg/dL) or severe hypoglycemia (nocturnal) (RR: 0.62; 95% CI: 0.39 to 0.97) [[53], [54]].Finally, the EDITION JP2 trial showed a reduction
hypoglycemia 71742 0.39 to 0.97) [[53], [54]].Finally, the EDITION JP2 trial showed a reduction in the risk of nocturnal hypoglycemia (≤70 mg/dL) over the week 9 to month 6, BL to month 6, and BL to month 12 periods (42%, 38%, and
hypoglycemia 71912 6, and BL to month 12 periods (42%, 38%, and 27% drop, resp.), as well as in the risk of at-any-time hypoglycemia (≤70 mg/dL) over the BL to week 8 period (31% reduction). Confirmed (≤70 mg/dL) or severe hypoglycemia
hypoglycemia 72023 hypoglycemia (≤70 mg/dL) over the BL to week 8 period (31% reduction). Confirmed (≤70 mg/dL) or severe hypoglycemia (nocturnal) over the 6 mo study period (annualized rates, events per participant-year) was lower with
hypoglycemia 72354 CI: 0.43 to 0.96; P = 0.030). At month 12, the annualized rate of confirmed (≤70 mg/dL) or severe hypoglycemia was lower with Glar-300 [RR: 0.41; 95% CI: 0.18 to 0.92 (nocturnal) and RR: 0.64; 95% CI: 0.44 to 0.94
hypoglycemia 72511 0.18 to 0.92 (nocturnal) and RR: 0.64; 95% CI: 0.44 to 0.94 (at any time)] [[55], [56]].The risks of hypoglycemia for Glar-300 versus Glar-100 in participants with T2DM and T1DM in the program of the EDITION phase
hypoglycemia 74422 pregnancy, changes from BL in laboratory variables, vital signs, body weight, electrocardiogram, and hypoglycemia [[61]–[63]].The proportion of patients with TEAEs and other relevant results in the EDITION phase
hypoglycemia 75005 Glar-100. At month 6, more than half of the patients experienced a decrease from BL in the perception of hypoglycemia (in favor of Glar-300). At month 12, the improvements in the mean total DTSQ score from BL for Glar-300
hypoglycemia 75188 total DTSQ score from BL for Glar-300 and Glar-100 were similar. Improvements in perceived frequency of hypoglycemia and perceived convenience were also similar between groups [[45], [46]].In the EDITION 2 trial, the
hypoglycemia 75456 score from BL to month 6 was similar in both groups (Glar-300 and Glar-100). The perceived frequency of hypoglycemia was also similar between groups. At month 12, the participants in both treatment groups reported high
hypoglycemia 75775 improvement in DTSQ scores observed at month 6 was maintained at month 12, and perceived frequency of hypoglycemia remained stable with either treatment [[47], [48]].In the EDITION 3 trial, the DTSQ improved from BL
hypoglycemia 76014 treatment groups. There was no change in the EQ-5D utility index score in either treatment group. Fear of hypoglycemia was low and decreased over the 6 mo study period in both treatment groups (with no significant differences
hypoglycemia 76406 index score remained stable in both treatment groups throughout the 12 mo study, and the fear of hypoglycemia was very low at BL and decreased further to month 12 in both treatment groups. The mean (SD) total HFS-II
hypoglycemia 78403 AIA titers in the Glar-300 (n = 16) versus Glar-100 (n = 17) groups experienced at least one severe hypoglycemia event. When analyzed by AIA titers, there were equal numbers of patients (2 patients) in each treatment
hypoglycemia 78588 (2 patients) in each treatment group, with high AIA titers and who experienced at least one severe hypoglycemia event. Neither of these studies included insulin-naïve patients [[47], [49]].In the EDITION 4 trial
hypoglycemia 79191 on-treatment period. Half as many patients in the Glar-300 group, AIA-positive patients experienced severe hypoglycemia compared to Glar-100 patients [11 (5.3%) versus 22 (10.4%)]. When analyzed by titers, there were more
hypoglycemia 79433 titers in the Glar-300 group (3 patients) versus the Glar-100 group (1 patient), who experienced severe hypoglycemia . Over the 12 mo period, the percentage of participants who were positive at any time for AIAs was
hypoglycemia 80173 from twice-daily basal insulin to once-daily Glar-300 or Glar-100 in T2DM; evaluation of the nocturnal hypoglycemia risk for Glar-300 versus Glar-100, using different definitions of nocturnal hypoglycemia windows; evaluation
hypoglycemia 80262 nocturnal hypoglycemia risk for Glar-300 versus Glar-100, using different definitions of nocturnal hypoglycemia windows; evaluation of the impact of age of diabetes onset on glycemic control, as well as on hypoglycemia
hypoglycemia 80369 hypoglycemia windows; evaluation of the impact of age of diabetes onset on glycemic control, as well as on hypoglycemia in T2DM treated with Glar-300 or Glar-100; efficacy and safety of Glar-300 using flexible-dosing or
hypoglycemia 80652 Glar-100 in different subgroups defined by age, BMI, and diabetes duration; the relationship between hypoglycemia and HbA1c in T2DM, comparing Glar-300 and Glar-100; the glycemic control and hypoglycemia benefits with
hypoglycemia 80742 relationship between hypoglycemia and HbA1c in T2DM, comparing Glar-300 and Glar-100; the glycemic control and hypoglycemia benefits with Glar-300 in T2DM and mild-to-moderate renal impairment; and comparison of the efficacy
hypoglycemia 82702 (95% CI: −0.89 to 0.93)].The annualized rate (events per participant-year) of confirmed or severe hypoglycemia at any time of the day over the 6 mo study period was 15.22 for Glar-300 and 17.73 for Glar-100 (rate
hypoglycemia 83193 and 3.06 for the Glar-100 group (rate ratio: 0.69; 95% CI: 0.57–0.84; P = 0.0002). A lower rate of hypoglycemia was shown during the night and beyond the predefined nocturnal period with Glar-300 compared with Glar-100.Events
hypoglycemia 83709 participant from having a confirmed or severe hypoglycemic event compared with Glar-100 was 16. For severe hypoglycemia , in the pooled analysis of all three studies, the number of participants with ≥1 event at any time
hypoglycemia 86744 included the change in laboratory-measured (clinic-collected) FPG and daily basal insulin doses and hypoglycemia occurring between the substudy BL and the end of the substudy. In total, 109 patients from the EDITION
hypoglycemia 88786 (at 21% and 23% in the flexible-dosing and fixed-dosing groups, resp.), and the annualized rates of hypoglycemia compared using any definition, at any time (24 h) and during the night, were similar with the flexible-dosing
hypoglycemia 90755 In both the EDITION 1 trial and the EDITION 2 trial, a lower risk of nocturnal confirmed or severe hypoglycemia was observed with once-daily Glar-300 versus once-daily Glar-100 in participants switching from twice-daily
hypoglycemia 90938 participants switching from twice-daily basal insulin. Similarly, a lower risk of confirmed or severe hypoglycemia at any time was also seen for Glar-300 versus Glar-100 in the EDITION 2 trial, regardless of the plasma
hypoglycemia 91738 meta-analysis of people with T2DM (from the EDITION 2, 3, and JP2 trials) assessed the risk of nocturnal hypoglycemia for Glar-300 versus Glar-100 using four different windows to define nocturnal hypoglycemia. The prespecified
hypoglycemia 91829 nocturnal hypoglycemia for Glar-300 versus Glar-100 using four different windows to define nocturnal hypoglycemia . The prespecified hypoglycemia endpoints were the same for each study and were based on ADA definitions;
hypoglycemia 91860 Glar-300 versus Glar-100 using four different windows to define nocturnal hypoglycemia. The prespecified hypoglycemia endpoints were the same for each study and were based on ADA definitions; confirmed or severe hypoglycemia
hypoglycemia 91967 hypoglycemia endpoints were the same for each study and were based on ADA definitions; confirmed or severe hypoglycemia was defined as any event that was documented symptomatic or asymptomatic with a plasma glucose measurement
hypoglycemia 92171 glucose measurement of ≤70 mg/dL or <54 mg/dL or severe. The events were reported as a pattern of hypoglycemia by the time of the day, percentage of participants with ≥1 event, and annualized rates (events per
hypoglycemia 92463 assessed by a study and in a patient-level meta-analysis.The windows used for evaluation of nocturnal hypoglycemia were per protocol, with events between 00:00 h and 05:59 h classified as nocturnal (predefined window);
hypoglycemia 93025 prebreakfast SMPG); finally, the percentage of participants with ≥1 hypoglycemic event and the rates of hypoglycemia per participant-year were estimated. In the patient-level meta-analysis, the median times of prebreakfast
hypoglycemia 93354 20:00–22:05), respectively. At every time point, fewer participants reported confirmed or severe hypoglycemia for Glar-300 than for Glar-100. The events were reported most frequently between 06:00 h and 08:00 h;
hypoglycemia 93898 extended windows). A similar pattern of lower risk for Glar-300 versus Glar-100 was seen with other hypoglycemia definitions. For the annualized rates of nocturnal hypoglycemia for confirmed or severe hypoglycemia,
hypoglycemia 93962 versus Glar-100 was seen with other hypoglycemia definitions. For the annualized rates of nocturnal hypoglycemia for confirmed or severe hypoglycemia, rates were 41% lower using the predefined window and 29–34%
hypoglycemia 93999 hypoglycemia definitions. For the annualized rates of nocturnal hypoglycemia for confirmed or severe hypoglycemia , rates were 41% lower using the predefined window and 29–34% lower using the extended windows [[67]].In
hypoglycemia 94325 6 mo (in the EDITION 1, 2, and 3 trials), the impact of age of diabetes onset on glycemic control and hypoglycemia was assessed. The subgroups were classified according to age of diabetes onset (<40 years, 40–50 years,
hypoglycemia 95022 relation to participants with ≥1 hypoglycemic event, the lower risk of nocturnal confirmed or severe hypoglycemia with Glar-300 versus Glar-100 was not affected by age of diabetes onset (no evidence of heterogeneity
hypoglycemia 95256 across subgroups, P = 0.17). The benefit of Glar-300 in terms of lower risk of confirmed or severe hypoglycemia at any time was consistently seen, regardless of age of diabetes onset (no evidence of heterogeneity
hypoglycemia 95422 of diabetes onset (no evidence of heterogeneity of treatment effect across subgroups, P = 0.31).The hypoglycemia benefit of Glar-300 versus Glar-100 at night and at any time of the day was also seen when using the
hypoglycemia 95595 of the day was also seen when using the stricter hypoglycemic threshold of <54 mg/dL; the severe hypoglycemia at any time was infrequent (≤3.6% in all subgroups over 6 mo) and no evidence of heterogeneity of
hypoglycemia 96272 EDITION 1, 2, and 3 trials evaluated the effects of Glar-300 versus Glar-100 on HbA1c reduction and hypoglycemia in different subgroups [age (<65 and ≥65 years), BMI (<30 and ≥30 kg/m2), and diabetes duration
hypoglycemia 98068 (RR: 0.88; 95% CI: 0.84 to 0.93).The heterogeneity of treatment effect across subgroups (P value) for hypoglycemia at any time of the day (24 h) was 0.927, 0.654, and 0.006 for age, BMI, and diabetes duration, respectively.
hypoglycemia 98206 (24 h) was 0.927, 0.654, and 0.006 for age, BMI, and diabetes duration, respectively. For nocturnal hypoglycemia in overall, the rates were 30% and 39.8% for the Glar-300 and Glar-100 groups, respectively (RR: 0.75;
hypoglycemia 99328 CI: 0.64 to 0.82). The heterogeneity of treatment effect across subgroups (P values) for nocturnal hypoglycemia was 0.366, 0.774, and 0.109 for age, BMI, and diabetes duration, respectively [[69]].On the other hand,
hypoglycemia 99985 duration (from BL to month 6) as an offset variable. The objective was to explore the relationship between hypoglycemia over 6 mo and HbA1c at month 6 in T2DM comparing Glar-300 and Glar-100, using the data from the EDITION
hypoglycemia 100292 Glar-100, respectively (patient-level meta-analysis); in total, 1055 and 1048 participants with available hypoglycemia and HbA1c data from the Glar-300 and Glar-100 groups, respectively, were included in the meta-analysis.The
hypoglycemia 100452 groups, respectively, were included in the meta-analysis.The annualized rates of confirmed or severe hypoglycemia at night and hypoglycemia at any time of the day were lower with Glar-300 versus Glar-100, regardless
hypoglycemia 100478 included in the meta-analysis.The annualized rates of confirmed or severe hypoglycemia at night and hypoglycemia at any time of the day were lower with Glar-300 versus Glar-100, regardless of HbA1c values at month
hypoglycemia 100760 significantly improve the goodness of fit (interaction P values were 0.829 and 0.937 for nocturnal hypoglycemia and at-any-time hypoglycemia, resp.). The authors concluded that, in the EDITION 1 trial, rates of hypoglycemia
hypoglycemia 100789 goodness of fit (interaction P values were 0.829 and 0.937 for nocturnal hypoglycemia and at-any-time hypoglycemia , resp.). The authors concluded that, in the EDITION 1 trial, rates of hypoglycemia were likely confounded
hypoglycemia 100872 and at-any-time hypoglycemia, resp.). The authors concluded that, in the EDITION 1 trial, rates of hypoglycemia were likely confounded by the fact that patients were taking mealtime insulin in addition to basal insulin
hypoglycemia 101234 the EDITION 1 and 2 trials (which possibly affected the ability to detect differences in the rates of hypoglycemia between the Glar-300 and Glar-100 groups in the EDITION 3 trial) [[70]].In a post hoc patient-level
hypoglycemia 101469 from the EDITION 1, 2, and 3 trials, the effects of Glar-300 versus Glar-100 on HbA1c reduction and hypoglycemia were assessed in renal function subgroups [BL estimated glomerular filtration rate (eGFR) ≥30 to <60,
hypoglycemia 102968 of treatment effect was demonstrated across the subgroups (P = 0.46).The risk of confirmed or severe hypoglycemia was significantly lower for nocturnal events and comparable or lower for at-any-time events for Glar-300
hypoglycemia 103193 Glar-100 across subgroups. Renal function did not affect the lower rate of nocturnal or at-any-time hypoglycemia . There was no evidence of heterogeneity of treatment effect across subgroups (P = 0.73 and P = 0.27
hypoglycemia 103353 treatment effect across subgroups (P = 0.73 and P = 0.27 for the rate ratio of nocturnal or at-any-time hypoglycemia , resp.) [[71]].In other post hoc patient-level meta-analysis of the EDITION 1, 2, and 3 trials, the
hypoglycemia 104500 0.65 to 0.97) hypoglycemic event with Glar-300 versus Glar-100. Over the 12 mo study period, severe hypoglycemia was reported by 13 (4.0%) participants in the Glar-300 group and 16 (4.8%) participants in the Glar-100
hypoglycemia 105490 patient-level data from the EDITION 2 and 3 trials that determined whether previously reported reductions in hypoglycemia were associated with Glar-300 compared with Glar-100 and impacted by a patient risk category in T2DM,
hypoglycemia 106152 The primary endpoint was a composite of patients achieving HbA1c target without confirmed or severe hypoglycemia over 6 mo in the different treatment groups.The mean (SD) change in HbA1c from BL to the 6 mo endpoint
hypoglycemia 106902 the low-risk cohort who were treated with Glar-300 (in the EDITION 2 trial) had confirmed or severe hypoglycemia compared with those treated with Glar-100 (68.3% versus 76.4%; P = 0.0245); this result was not found
hypoglycemia 107201 there was no significant difference in the proportion of individuals experiencing confirmed or severe hypoglycemia when treated with Glar-300 compared with Glar-100 in either study.The events per patient-year of confirmed
hypoglycemia 107331 Glar-300 compared with Glar-100 in either study.The events per patient-year of confirmed or severe hypoglycemia in the EDITION 2 trial (for Glar-300 versus Glar-100) were as follows: low risk: 13.4 versus 17.1 events
hypoglycemia 107851 participants in the low-risk cohort who were treated with Glar-300 had a lower incidence of nocturnal hypoglycemia than those treated with Glar-100 in the EDITION 2 trial (29.8% versus 41.8%, P = 0.002), whereas those
hypoglycemia 108151 high-risk cohort, patients treated with Glar-300 showed a nonsignificant trend toward lower nocturnal hypoglycemia compared with those treated with Glar-100 [25.3% versus 38.0% (P = 0.0678) for the EDITION 2 trial and
hypoglycemia 108347 EDITION 2 trial and 24.2% versus 32.7% (P = 0.1903) for the EDITION 3 trial]. The rate of nocturnal hypoglycemia in the EDITION 2 trial for both cohorts was significantly lower for those treated with Glar-300 versus
hypoglycemia 109209 OADs with reductions in prior OAD therapy without compromising impact on HbA1c, while preserving the hypoglycemia benefit of Glar-300 versus Glar-100. Patient-level data from the randomized controlled EDITION 3 trial
hypoglycemia 109831 6 mo after initiating either Glar-300 or Glar-100, while preserving the relative protection from hypoglycemia previously demonstrated with Glar-300. Consistent with these results, the real-world data also demonstrated
hypoglycemia 110114 BL versus 23% at 6 mo (n = 6430)] following Glar-300 or Glar-100 initiation, with a lower risk of hypoglycemia with Glar-300 compared with Glar-100. These data suggest that patients treated with Glar-300 could step
hypoglycemia 110295 patients treated with Glar-300 could step down OAD use without sacrificing glycemic control and with less hypoglycemia than those treated with Glar-100 [[74]].A recent retrospective study (DELIVER 3) examined the performance
hypoglycemia 110519 Glar-300 in older patients with T2DM in real-world clinical settings focusing on glycemic control and hypoglycemia risk. The Predictive Health Intelligence Environment database (representing 26 integrated healthcare
hypoglycemia 110962 ≥12 mo of BL data and ≥6 mo of follow-up data. The effect of the cohort on HbA1c reduction, hypoglycemia incidence/event rate, and achievement of HbA1c goal at 6 mo was assessed by generalized linear models
hypoglycemia 111745 0.967 (95% CI: 0.749 to 1.248; P = 0.797)]. Patients switched to Glar-300 were 57% less likely to have hypoglycemia at 6 mo follow-up [OR: 0.432 (95% CI: 0.307 to 0.607, P < 0.0001)]. After adjusting for BL characteristics,
hypoglycemia 111868 follow-up [OR: 0.432 (95% CI: 0.307 to 0.607, P < 0.0001)]. After adjusting for BL characteristics, hypoglycemia event rates were also significantly lower in the Glar-300 cohort [LS mean difference: −4.94 events/100
hypoglycemia 112138 settings, switching to Glar-300 in older patients with T2DM is associated with significantly lower hypoglycemia risk and similar glycemic control compared to switching to other basal insulins [[75]].6. DiscussionOverall,
hypoglycemia 115078 with Glar-100. The risk of experiencing ≥1 confirmed (BG ≤ 70 mg/dL) or severe episode of hypoglycemia (nocturnal and at-any-time hypoglycemia) was significantly reduced in the EDITION trials. Such reduction,
hypoglycemia 115118 ≥1 confirmed (BG ≤ 70 mg/dL) or severe episode of hypoglycemia (nocturnal and at-any-time hypoglycemia ) was significantly reduced in the EDITION trials. Such reduction, however, was not consistent in all
hypoglycemia 115271 EDITION trials. Such reduction, however, was not consistent in all trials or in all of the definitions of hypoglycemia . For example, the reduced risk of hypoglycemia was more significant (at month 6) in the EDITION 2 trial
hypoglycemia 115318 consistent in all trials or in all of the definitions of hypoglycemia. For example, the reduced risk of hypoglycemia was more significant (at month 6) in the EDITION 2 trial versus the EDITION 1 trial (it may be likely
hypoglycemia 115558 fast-acting analogue insulin in the EDITION 1 trial has impacted the difference found in the reduced risk of hypoglycemia between both trials). Despite the difference shown, it should be highlighted that the number of severe
hypoglycemia 115978 of hypoglycemic events was low, which may account for the reduced risk of nocturnal and at-any-time hypoglycemia . Significant differences were only reached over the BL to month 6 period (nocturnal hypoglycemia).Another
hypoglycemia 116075 at-any-time hypoglycemia. Significant differences were only reached over the BL to month 6 period (nocturnal hypoglycemia ).Another finding was that, throughout the EDITION trials, the goal of reducing the risk of hypoglycemia
hypoglycemia 116179 hypoglycemia).Another finding was that, throughout the EDITION trials, the goal of reducing the risk of hypoglycemia (at any time) during the follow-up period from week 9 to month 6 was not met. This may be due to the
hypoglycemia 116454 over to Glar-300. Hence, the results observed during the maintenance phase (for this definition of hypoglycemia ) could have been affected by the “learning” process of patients when using a new basal insulin.
hypoglycemia 116592 by the “learning” process of patients when using a new basal insulin. Nonetheless, the risk of hypoglycemia (nocturnal) over the same follow-up period (week 9 to month 6) was reduced in the EDITION 1, 2, and
hypoglycemia 116729 same follow-up period (week 9 to month 6) was reduced in the EDITION 1, 2, and JP2 trials. The risk of hypoglycemia (at any time) over the BL to month 12 period was only reduced in the EDITION 1 trial, without any significant
hypoglycemia 116917 EDITION 1 trial, without any significant differences with the other EDITION trials for this definition of hypoglycemia . The risk of nocturnal hypoglycemia ≤ 70 mg/dL was reduced in the EDITION 1 and 2 trials (for
hypoglycemia 116953 differences with the other EDITION trials for this definition of hypoglycemia. The risk of nocturnal hypoglycemia ≤ 70 mg/dL was reduced in the EDITION 1 and 2 trials (for all follow-up periods), while in the
hypoglycemia 117364 month 12.The treatment effect was less consistent with regard to the risk of documented symptomatic hypoglycemia < 54 mg/dL (BL to month 6). A significant reduction in the risk of hypoglycemia (at any time)
hypoglycemia 117450 documented symptomatic hypoglycemia < 54 mg/dL (BL to month 6). A significant reduction in the risk of hypoglycemia (at any time) was shown in the EDITION 2 trial, while in the EDITION 3 trial, the risk of hypoglycemia,
hypoglycemia 117553 hypoglycemia (at any time) was shown in the EDITION 2 trial, while in the EDITION 3 trial, the risk of hypoglycemia , both at-any-time and nocturnal, was reduced and in the EDITION JP1 trial, the risk of nocturnal hypoglycemia
hypoglycemia 117663 hypoglycemia, both at-any-time and nocturnal, was reduced and in the EDITION JP1 trial, the risk of nocturnal hypoglycemia was lowered. No differences in the risk of this definition of hypoglycemia were found in the EDITION
hypoglycemia 117738 trial, the risk of nocturnal hypoglycemia was lowered. No differences in the risk of this definition of hypoglycemia were found in the EDITION 1, 4, and JP2 trials with Glar-300 versus Glar-100. Furthermore, during the
hypoglycemia 117945 during the BL to month 12 follow-up period, a significant reduction was noted in the risk of nocturnal hypoglycemia in the JP1 trial, as well as a significant difference in the risk reduction with Glar-300 for at-any-time
hypoglycemia 118064 JP1 trial, as well as a significant difference in the risk reduction with Glar-300 for at-any-time hypoglycemia in the EDITION 3 trial (with no significant differences in the EDITION 1, 2, JP1, and JP2 trials with
hypoglycemia 118232 in the EDITION 1, 2, JP1, and JP2 trials with regard to that risk).Such differences in the risk of hypoglycemia may be explained at least partially, because when comparing “unit by unit” Glar-300 versus Glar-100,
hypoglycemia 119109 regimens).The relative underdosing of the patients receiving Glar-300 could have impacted the lower risk of hypoglycemia , particularly considering the high threshold defined (BG ≤ 70 mg/dL). This may also explain
hypoglycemia 119271 defined (BG ≤ 70 mg/dL). This may also explain the lower effect on the reduction of the risk of hypoglycemia when using a more demanding threshold (BG ≤ 54 mg/dL). Consequently, a general statement may
hypoglycemia 119450 Consequently, a general statement may claim that the use of Glar-300 significantly reduced the risk of hypoglycemia [particularly nocturnal hypoglycemia (BG ≤ 70 mg/dL)] compared to that of Glar-100 in T2DM and
hypoglycemia 119487 claim that the use of Glar-300 significantly reduced the risk of hypoglycemia [particularly nocturnal hypoglycemia (BG ≤ 70 mg/dL)] compared to that of Glar-100 in T2DM and T1DM individuals, with a favorable
hypoglycemia 119649 Glar-100 in T2DM and T1DM individuals, with a favorable effect, though less significant, on the risk of hypoglycemia (BG ≤ 70 mg/dL) at any time and on the risk of documented symptomatic hypoglycemia at any time
hypoglycemia 119740 risk of hypoglycemia (BG ≤ 70 mg/dL) at any time and on the risk of documented symptomatic hypoglycemia at any time and night (BG ≤ 54 mg/dL). This further proves that the time of administration (morning
hypoglycemia 119917 proves that the time of administration (morning or evening, in T1DM) makes no difference in the risk of hypoglycemia . These aspects associated with Glar-300 may be explained, at least in part, by the smoother, more even
hypoglycemia 123501 (notwithstanding a similar glycemic control between Glar-300 and Glar-100) reflect the lower risk of hypoglycemia shown with Glar-300. In other words, if the risk of hypoglycemia was higher among the Glar-100 patients,
hypoglycemia 123566 Glar-100) reflect the lower risk of hypoglycemia shown with Glar-300. In other words, if the risk of hypoglycemia was higher among the Glar-100 patients, it is likely that the approaches to overcome the hypoglycemic
hypoglycemia 125754 of discontinuations were not safety related; single cases were due to perceived lack of efficacy or hypoglycemia ; however, these cases were balanced between groups. The most common AEs were infections, nervous system
hypoglycemia 126840 Glar-300 was injected up to 3 h before or after the usual time of administration, with low rates of hypoglycemia and AEs (and similar control in the levels of HbA1c). It was also found that the switching from twice-daily
hypoglycemia 127139 with comparable decreases in both treatment groups and a lower risk of nocturnal confirmed or severe hypoglycemia observed with once-daily Glar-300 versus once-daily Glar-100 in participants switching from twice-daily
hypoglycemia 127369 insulin. On the other hand, it was also found that Glar-300 provided comparable glycemic control with less hypoglycemia , regardless of age of diabetes onset, age, BMI, diabetes duration, and renal function. The results of
hypoglycemia 129007 number of people with T1DM or T2DM may benefit from the use of Glar-300, such as people at high risk of hypoglycemia or patients with a high rate of hypoglycemic events while in treatment with Glar-100. Individuals requiring
hypoglycemia 130078 Glar-300 (versus switching to other basal insulins) is associated with a significantly lower risk of hypoglycemia , potentially resulting in higher patient satisfaction and better compliance and persistence with therapy.
hypoglycemia 131194 complications with respect to other basal insulins. It should also be established whether the lower risk of hypoglycemia in individuals ≥ 65 years translates into lower healthcare resource utilization.6.4. ConclusionsThroughout
hypoglycemia 131473 control goals achieved with Glar-300 were similar to those achieved with Glar-100, with a lower risk of hypoglycemia and less weight gain. These results suggest that Glar-300 may have a place as an alternative, long-acting
hypoglycemia 135790 300 U/mL; LS: least squares; NS: not significant; SMPG: self-monitored plasma glucose.Table 3Risk of hypoglycemia for Glar-300 versus Glar-100 in participants with T2DM and T1DM in the EDITION phase 3 clinical trial
hypoglycemia 136046 periodRelative risk of experiencing ≥1 confirmed (blood glucose ≤ 70 mg/dL) or severe episode of hypoglycemia (95% CI)Relative risk (95% CI) of documented symptomatic hypoglycemia (<54 mg/dL)Nocturnal (00:00–05:59 h)At
hypoglycemia 136116 glucose ≤ 70 mg/dL) or severe episode of hypoglycemia (95% CI)Relative risk (95% CI) of documented symptomatic hypoglycemia (<54 mg/dL)Nocturnal (00:00–05:59 h)At any time (24 h)At any timeNocturnalBL to W8W9 to month
hypoglycemia 137409 periodRelative risk of experiencing ≥1 confirmed (blood glucose ≤ 70 mg/dL) or severe episode of hypoglycemia (95% CI)Relative risk (95% CI) of documented symptomatic hypoglycemia (<54 mg/dL)Nocturnal (00:00–05:59 h)
hypoglycemia 137479 glucose ≤ 70 mg/dL) or severe episode of hypoglycemia (95% CI)Relative risk (95% CI) of documented symptomatic hypoglycemia (<54 mg/dL)Nocturnal (00:00–05:59 h) BL to month 12At any time (24 h) BL to month 12BL to month
obesity 2417 population. This phenomenon is due to the increase in associated risk factors, such as overweight or obesity [[1], [2]]. According to the International Diabetes Federation, 415 million people worldwide, or 8.8%
type 1 diabetes mellitus 787 is considered the most effective glucose-lowering therapy available and is required by people with type 1 diabetes mellitus to control their blood glucose levels; yet, many people with type 2 diabetes mellitus will also eventually
type 1 diabetes mellitus 138224 2.55)BL: baseline; Glar-100: insulin glargine 100 U/mL; Glar-300: insulin glargine 300 U/mL; T1DM: type 1 diabetes mellitus ; T2DM: type 2 diabetes mellitus; W8: week 8; W9: week 9.Table 4Proportion of patients with TEAEs, drop-out
type 2 diabetes mellitus 873 by people with type 1 diabetes mellitus to control their blood glucose levels; yet, many people with type 2 diabetes mellitus will also eventually require insulin therapy, due to the progressive nature of the disease. A variety
type 2 diabetes mellitus 1742 glargine-300 versus glargine-100 from the EDITION clinical trial program, in patients with type 1 and type 2 diabetes mellitus .1. IntroductionThe frequency of diabetes mellitus (DM) has increased worldwide, leading to a huge social,
type 2 diabetes mellitus 138256 insulin glargine 100 U/mL; Glar-300: insulin glargine 300 U/mL; T1DM: type 1 diabetes mellitus; T2DM: type 2 diabetes mellitus ; W8: week 8; W9: week 9.Table 4Proportion of patients with TEAEs, drop-out rates, and rescue therapy

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