15 Years of Experience with Biphasic Insulin Aspart 30 in Type 2 Diabetes.

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Insulin Aspart 2 endocrinologydiseasesdrugs
diabetes mellitus 6 endocrinologydiseases
hypoglycemia 37 endocrinologydiseases
metformin 3 endocrinologydiseasesdrugs
sitagliptin 14 endocrinologydiseasesdrugs
type 1 diabetes mellitus 1 endocrinologydiseases
type 2 diabetes mellitus 4 endocrinologydiseases
Insulin 6 endocrinologydiseasesdrugs

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Insulin 56 Title: Drugs in R&D15 Years of Experience with Biphasic Insulin Aspart 30 in Type 2 DiabetesAndreas LieblViswanathan MohanWenying YangKrzysztof StrojekSultan LinjawiPublication
Insulin 5471 additional papers, for a total of 35 relevant papers.Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 (BIAsp 30)As reviewed previously [[1]], the PK profile of BIAsp 30 more closely mimics normal
Insulin 9051 spent significantly less time under conditions of hypoglycemia than those using BIAsp 30 TID.Initiating Insulin Therapy with BIAsp 30Progressive deterioration of β-cell function in T2DM means most patients will
Insulin 9347 control with oral antidiabetic drugs (OADs) in conjunction with dietary and lifestyle adjustments. Insulin -naïve patients may be fearful of injections and worry about the practical burden of therapy [[4]],
Insulin 24732 to IGlar OD plus a single injection of insulin glulisine at the largest meal (basal-plus regimen). Insulin doses were titrated weekly in both groups up to week 14, and then once every 2 weeks, following a protocol-specified
Insulin 47169 30 can be combined safely and effectively with the popular modern OAD sitagliptin [[6], [19], [23]]. Insulin therapies using BIAsp 30 compare favorably to intensification with an IGlar + insulin glulisine basal-plus
Insulin Aspart 56 Title: Drugs in R&D15 Years of Experience with Biphasic Insulin Aspart 30 in Type 2 DiabetesAndreas LieblViswanathan MohanWenying YangKrzysztof StrojekSultan LinjawiPublication
Insulin Aspart 5471 additional papers, for a total of 35 relevant papers.Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 (BIAsp 30)As reviewed previously [[1]], the PK profile of BIAsp 30 more closely mimics normal physiologically
metformin 11859 either BIAsp 30 or IGlar U100, each taken OD [[6]]. OADs were standardized to glimepiride 4 mg/day and metformin 1500 or 2500 mg/day before randomization. Doses of both insulins were titrated to a pre-breakfast fasting
metformin 19779 strategies for initiating insulin therapy in patients with T2DM poorly controlled with sitagliptin + metformin (Sit2Mix) [[18]]. In that open-label, 24-week trial, 582 insulin-naïve patients were randomized to
metformin 20030 BIAsp 30 BID added to sitagliptin, or BIAsp 30 BID without sitagliptin. All groups continued to use metformin . After 24 weeks, the reduction in HbA1c was significantly greater in the group administering BIAsp 30
sitagliptin 19763 has compared strategies for initiating insulin therapy in patients with T2DM poorly controlled with sitagliptin + metformin (Sit2Mix) [[18]]. In that open-label, 24-week trial, 582 insulin-naïve patients were
sitagliptin 19917 open-label, 24-week trial, 582 insulin-naïve patients were randomized to either BIAsp 30 OD added to sitagliptin , BIAsp 30 BID added to sitagliptin, or BIAsp 30 BID without sitagliptin. All groups continued to use
sitagliptin 19952 insulin-naïve patients were randomized to either BIAsp 30 OD added to sitagliptin, BIAsp 30 BID added to sitagliptin , or BIAsp 30 BID without sitagliptin. All groups continued to use metformin. After 24 weeks, the reduction
sitagliptin 19989 either BIAsp 30 OD added to sitagliptin, BIAsp 30 BID added to sitagliptin, or BIAsp 30 BID without sitagliptin . All groups continued to use metformin. After 24 weeks, the reduction in HbA1c was significantly greater
sitagliptin 20147 24 weeks, the reduction in HbA1c was significantly greater in the group administering BIAsp 30 with sitagliptin than in the group using BIAsp 30 OD with sitagliptin (treatment difference: − 0.36% [95% CI − 0.54
sitagliptin 20200 greater in the group administering BIAsp 30 with sitagliptin than in the group using BIAsp 30 OD with sitagliptin (treatment difference: − 0.36% [95% CI − 0.54 to − 0.17]; p < 0.001) as well as versus BIAsp
sitagliptin 20331 difference: − 0.36% [95% CI − 0.54 to − 0.17]; p < 0.001) as well as versus BIAsp 30 BID without sitagliptin (treatment difference: 0.24% [95% CI 0.06–0.43]; p < 0.01). The proportions of people reaching HbA1c
sitagliptin 20513 proportions of people reaching HbA1c < 7% were 59.8, 46.5, and 49.7% for BIAsp 30 BID, BIAsp 30 OD + sitagliptin , and BIAsp 30 BID without sitagliptin, respectively. Postprandial plasma glucose (PPG) was also reduced
sitagliptin 20551 < 7% were 59.8, 46.5, and 49.7% for BIAsp 30 BID, BIAsp 30 OD + sitagliptin, and BIAsp 30 BID without sitagliptin , respectively. Postprandial plasma glucose (PPG) was also reduced after breakfast for all patients,
sitagliptin 20859 events was 2.24 episodes/patient-year with BIAsp 30 BID, 1.50 episodes/patient-year for BIAsp 30 BID + sitagliptin , and 1.17 episodes/patient-year for BIAsp 30 OD + sitagliptin. Overall, each of the regimens was well
sitagliptin 20923 episodes/patient-year for BIAsp 30 BID + sitagliptin, and 1.17 episodes/patient-year for BIAsp 30 OD + sitagliptin . Overall, each of the regimens was well tolerated, suggesting that several suitable treatment options
sitagliptin 21155 according to the needs of the patient. The combination of BIAsp 30 with the more widely used modern OAD sitagliptin was deemed safe and effective.The combination of BIAsp 30 with other modern OADs, namely sodium-glucose
sitagliptin 46914 in insulin-naïve patients in primary care practice [[7]–[9]].BIAsp 30 administered OD or BID with sitagliptin has been shown to have statistically significant advantages over BIAsp 30 alone when initiated in insulin-naïve
sitagliptin 47138 patients [[18]]. Thus, BIAsp 30 can be combined safely and effectively with the popular modern OAD sitagliptin [[6], [19], [23]]. Insulin therapies using BIAsp 30 compare favorably to intensification with an IGlar + insulin
Select Disease Character Offset Disease Term Instance
diabetes mellitus 352 (ppub): 3/2018AbstractSince clinical experience with biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes mellitus (T2DM) was reviewed in 2012 after 10 years of use worldwide, additional studies have been published
diabetes mellitus 2176 with T2DM.Key PointsEvidence from new studies including unselected populations of patients with type 2 diabetes mellitus (T2DM) confirms that BIAsp 30 has advantages over regular human insulin.Patients with T2DM can safely
diabetes mellitus 2864 (PK) and pharmacodynamic (PD) advantages of an analog-based insulin formulation for people with type 2 diabetes mellitus (T2DM). In 2012, after 10 years of use of BIAsp 30 in millions of patients worldwide, a review co-written
diabetes mellitus 33358 and the value of SMPG and patient-directed titration of insulin dose has been established for type 1 diabetes mellitus [[30], [31]]. Studies have demonstrated the effectiveness of patient-driven titration in T2DM using
diabetes mellitus 37474 regulatory purposes). In one pilot study, BIAsp 30 was compared with premixed human insulin in gestational diabetes mellitus (GDM) [[38]]. A total of 76 women with GDM and mean gestation of ~23 weeks at entry were randomized
diabetes mellitus 44209 oral antidiabetic drug, QALY quality-adjusted life-year, RCT randomized controlled trial, T2DM type 2 diabetes mellitus The cost effectiveness of BIAsp 30 versus NPH insulin + regular human insulin for insulin-naïve patients
hypoglycemia 6750 excursion (MAGE) was also significantly lower with BIAsp 30 (p < 0.05). There were no problems with hypoglycemia with either treatment.Fig. 1Average glucose profile during BHI 30 or BIAsp 30 treatment using 48-h
hypoglycemia 8563 fluctuations for both newly diagnosed patients and those with longstanding diabetes. No episodes of serious hypoglycemia were recorded in any of the groups, but the time spent in conditions of hypoglycemia (defined as sensor
hypoglycemia 8648 episodes of serious hypoglycemia were recorded in any of the groups, but the time spent in conditions of hypoglycemia (defined as sensor glucose values < 3.9 mmol/l) was significantly reduced (p < 0.01) after each treatment
hypoglycemia 8997 assigned to CSII and glargine basal–bolus therapy spent significantly less time under conditions of hypoglycemia than those using BIAsp 30 TID.Initiating Insulin Therapy with BIAsp 30Progressive deterioration of β-cell
hypoglycemia 9945 with BIAsp 30 than with IGlar [[1]]. BIAsp 30 offers the advantage of convenience and a lower risk of hypoglycemia compared with a basal–bolus regimen for insulin-naïve patients.A meta-analysis of five previously
hypoglycemia 15583 (p < 0.001) [[9]]. However, only 22% (n = 12) achieved HbA1c < 7.0%. There were 3.4 episodes of minor hypoglycemia per patient-year. Only one episode of severe hypoglycemia was reported. A lack of improvement in post-lunch
hypoglycemia 15641 < 7.0%. There were 3.4 episodes of minor hypoglycemia per patient-year. Only one episode of severe hypoglycemia was reported. A lack of improvement in post-lunch glycemic control in these comparatively more insulin-deficient
hypoglycemia 17031 study was conducted to assess predictors of reaching a composite endpoint of HbA1c < 7.0% without hypoglycemia 6 months after initiating therapy [[12]]. Data from 28,696 patients were included in evaluation of
hypoglycemia 17497 all patients (insulin-naïve and BHI 30, both p < 0.0001; basal insulin, p = 0.0471). A lack of hypoglycemia at baseline was a significant predictor for insulin-naïve patients and patients switching from BHI
hypoglycemia 19204 patients using BIAsp 70. Overall, HbA1c improved from baseline; at the same time, the incidence of hypoglycemia did not change during the period of observation. However, outcomes were not reported separately for
hypoglycemia 24118 achieving HbA1c < 7.0% (44.9% with BIAsp 30 1-2-3 and 40.3% with IDet + IAsp) and with similar rates of hypoglycemia (9.4 events/patient-year with BIAsp 30 1-2-3 and 9.8 events/patient-year for IDet + IAsp).The comparability
hypoglycemia 25356 (0.44 kg [95% CI 0.37–1.12]; p = 0.20), with a gain of roughly 2 kg in each group. The incidence of hypoglycemia was also similar between treatments (18.2 vs. 15.3 events/patient-year, for BIAsp 30 and basal-plus,
hypoglycemia 25581 respectively), estimated rate ratio 0.84 (95% CI 0.64–1.11; p = 0.22). However, the incidence of nocturnal hypoglycemia was higher with the basal-plus regimen (5.7 vs. 3.6 events/patient-year, rate ratio 1.57 [95% CI 1.08–2.29];
hypoglycemia 27026 − 0.09% [95% CI − 0.35 to 0.16]). During the initial 12-week titration period, the rate of overall hypoglycemia was lower for BIAsp 30 (p = 0.0020); afterwards, the rate was not significantly different between
hypoglycemia 29346 to −0.10]). Furthermore, there were fewer episodes of confirmed, nocturnal confirmed, and severe hypoglycemia with IDegAsp than with BIAsp 30 in the global population [[24]]. The rates of confirmed and nocturnal
hypoglycemia 30194 extended and confirmed in a meta-analysis of data from the two trials [[26]]. Rates of overall confirmed hypoglycemia and nocturnal confirmed hypoglycemia were statistically significantly lower, by 19% and 57%, respectively,
hypoglycemia 30231 of data from the two trials [[26]]. Rates of overall confirmed hypoglycemia and nocturnal confirmed hypoglycemia were statistically significantly lower, by 19% and 57%, respectively, for IDegAsp (estimated rate ratio
hypoglycemia 30737 treat-to-target trial in five European countries were consistent with the above findings [[27]]. With respect to hypoglycemia , patients using IDegAsp had a 58% lower rate of confirmed hypoglycemia than those using BIAsp 30 (rate
hypoglycemia 30808 findings [[27]]. With respect to hypoglycemia, patients using IDegAsp had a 58% lower rate of confirmed hypoglycemia than those using BIAsp 30 (rate ratio 0.42 [95% CI 0.23–0.75]). The reported incidence of AEs was
hypoglycemia 31554 difference IDegAsp–BIAsp 30, −1.4 U [95% CI −3.7 to 0.08]). There were no episodes of severe hypoglycemia in either group, and the proportion of patients experiencing confirmed non-severe episodes was similar
hypoglycemia 31778 for IDegAsp, 59.4% for BIAsp 30). The number of patients experiencing non-severe nocturnal confirmed hypoglycemia was low (1–2 events per patient-year) and similar between groups (rate ratio 0.49 U [95% CI 0.10–2.38]).The
hypoglycemia 34727 38.5%; p = 0.032) or ≤6.5% (12.1 vs. 20.7%; p = 0.023), as well as reaching these targets without hypoglycemia (19.5 vs. 28.2%, p = 0.042; and 8.0 vs. 16.1%, p = 0.018, respectively). There were no significant differences
hypoglycemia 34862 0.042; and 8.0 vs. 16.1%, p = 0.018, respectively). There were no significant differences in rate of hypoglycemia (rate ratio 0.77 [95% CI 0.54–1.09]); however, subjects in the patient-directed titration group did
hypoglycemia 35814 numerically greater number of subjects in the patient-driven group achieved this target without confirmed hypoglycemia (51.2 vs. 45.9%; p = 0.23).The effectiveness of patient-directed titration of BIAsp 30 was also demonstrated
hypoglycemia 37138 titration were not statistically significant. Similar results were observed when comparing incidence of hypoglycemia between the two groups.BIAsp 30 in Special PopulationsA few new studies have examined the efficacy and
hypoglycemia 40264 composite endpoint of treatment success in the IMPROVE trial (i.e. HbA1c ≤8% without experiencing hypoglycemia ), which included 28,696 patients [[12]]. Those results indicated that patients with lower baseline HbA1c
hypoglycemia 40465 lower baseline HbA1c (≤8%), shorter duration of diabetes (<5 years), and no incidence of either major hypoglycemia within 13 weeks prior to the trial or minor hypoglycemia within 4 weeks prior to the trial were associated
hypoglycemia 40522 (<5 years), and no incidence of either major hypoglycemia within 13 weeks prior to the trial or minor hypoglycemia within 4 weeks prior to the trial were associated with treatment success.Cost EffectivenessHealth-economic
hypoglycemia 41903 patients were able to obtain improvements in glycemic control without clinically important problems with hypoglycemia or weight gain and with improvements in quality of life [[41]]. The economic impact of switching from
hypoglycemia 43807 yearsICER 81,507.91 DKK per QALY for IDegAspCost effectiveness driven mainly by reduction in severe hypoglycemia BHI 30 biphasic human insulin 30, BIAsp 30 biphasic insulin aspart 30, BID twice daily administration,
hypoglycemia 45178 short-term model was deemed more appropriate for evaluating the influence of secondary endpoints such as hypoglycemia , body weight, and insulin dose on cost effectiveness. IDegAsp was determined to be cost effective versus
hypoglycemia 45342 effectiveness. IDegAsp was determined to be cost effective versus BIAsp 30, mainly due to a reduction in severe hypoglycemia .Quality of LifeIn the A1chieve study, health-related quality of life measured with a visual analog scale
hypoglycemia 47814 in the more global population being a statistically significant reduction in incidence of nocturnal hypoglycemia and a lower total insulin dose [[24]], as to be expected from the unique PK data of IDegAsp. A lower
hypoglycemia 47954 dose [[24]], as to be expected from the unique PK data of IDegAsp. A lower risk of overall confirmed hypoglycemia , nocturnal confirmed hypoglycemia, and severe hypoglycemia for IDegAsp versus BIAsp 30 was also demonstrated
hypoglycemia 47988 the unique PK data of IDegAsp. A lower risk of overall confirmed hypoglycemia, nocturnal confirmed hypoglycemia , and severe hypoglycemia for IDegAsp versus BIAsp 30 was also demonstrated in a meta-analysis [[26]].Large
hypoglycemia 48013 IDegAsp. A lower risk of overall confirmed hypoglycemia, nocturnal confirmed hypoglycemia, and severe hypoglycemia for IDegAsp versus BIAsp 30 was also demonstrated in a meta-analysis [[26]].Large observational studies
hypoglycemia 48369 BIAsp 30 (e.g. lower HbA1c at baseline, shorter duration of diabetes, lower BMI, and lack of history of hypoglycemia ) [[12]]. These results reinforce the value of initiating or optimizing treatment sooner rather than
type 1 diabetes mellitus 33351 therapy, and the value of SMPG and patient-directed titration of insulin dose has been established for type 1 diabetes mellitus [[30], [31]]. Studies have demonstrated the effectiveness of patient-driven titration in T2DM using
type 2 diabetes mellitus 345 date (ppub): 3/2018AbstractSince clinical experience with biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes mellitus (T2DM) was reviewed in 2012 after 10 years of use worldwide, additional studies have been published
type 2 diabetes mellitus 2169 patients with T2DM.Key PointsEvidence from new studies including unselected populations of patients with type 2 diabetes mellitus (T2DM) confirms that BIAsp 30 has advantages over regular human insulin.Patients with T2DM can safely
type 2 diabetes mellitus 2857 pharmacokinetic (PK) and pharmacodynamic (PD) advantages of an analog-based insulin formulation for people with type 2 diabetes mellitus (T2DM). In 2012, after 10 years of use of BIAsp 30 in millions of patients worldwide, a review co-written
type 2 diabetes mellitus 44202 OAD oral antidiabetic drug, QALY quality-adjusted life-year, RCT randomized controlled trial, T2DM type 2 diabetes mellitus The cost effectiveness of BIAsp 30 versus NPH insulin + regular human insulin for insulin-naïve patients

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