Efficacy and safety of premixed insulin analogs in Asian patients with type 2 diabetes: A systematic review

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Term Occurence Count Dictionary
type 2 diabetes mellitus 2 endocrinologydiseases
Insulin 14 endocrinologydiseasesdrugs
diabetes mellitus 5 endocrinologydiseases
hyperglycemia 1 endocrinologydiseases
hypoglycemia 33 endocrinologydiseases
metformin 1 endocrinologydiseasesdrugs
pioglitazone 2 endocrinologydiseasesdrugs

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Select Drug Character Offset Drug Term Instance
Insulin 11430 OL 48 weeks HbA1c ≥7.0 and ≤11.0%, insulin naïveOADs LM25 East Asian (n = 45) Caucasian (n = 69) Insulin glargine + insulin lispro East Asian (n = 44) Caucasian (n = 61) Continuation of OADs (all patients) LM25
Insulin 11670 progressing to thrice daily (doses titrated to achieve FBG/pre‐evening meal BG 4.5–6.0 mmol/L) Insulin glargine once daily at bedtime (dose titrated to achieve FBG 4.5–6.0 mmol/L) + insulin lispro up to
Insulin 12833 HbA1c <6.5% NR Hirao (2009)20 Japan R, OL 6 months HbA1c ≥8.0, insulin naïveOADs BIAsp30 (n = 80) Insulin aspart ± NPH insulin (n = 80)† BIAsp30 twice daily Insulin aspart thrice daily‡ All doses titrated
Insulin 12895 ≥8.0, insulin naïveOADs BIAsp30 (n = 80) Insulin aspart ± NPH insulin (n = 80)† BIAsp30 twice daily Insulin aspart thrice daily‡ All doses titrated to achieve HbA1c <7.0% Japan Diabetes Foundation Lee (2011)31 Korea R,
Insulin 13099 (2011)31 Korea R, OL 16 weeks Previous SU treatment, HbA1c >7.5%, insulin naïveSU BIAsp30 (n = 59) Insulin detemir (n = 61) Continuation non‐SU OADs (all patients) Once daily (doses titrated to achieve fasting
Insulin 13721 Japan R, OL 24 weeks HbA1c ≥7.0 and ≤10.0%, FPG ≥6.1 mmol/L, insulin naïveOADs BIAsp30 (n = 261) Insulin glargine (n = 260) GLIM + MET (all patients) Once daily (doses titrated to achieve prebreakfast FPG
Insulin 16540 weeks HbA1c 7.0–12.0% on twice‐daily premixed insulinPremixed insulin ± OADs LM50 + LM25 (n = 197) Insulin glargine + insulin lispro (n = 202) Continuation of OADs (all patients) LM50 before breakfast & lunch
Insulin 16672 lispro (n = 202) Continuation of OADs (all patients) LM50 before breakfast & lunch + LM25 before dinner Insulin glargine at bedtime + insulin lispro before each meal All doses titrated to achieve preprandial BG <6.1
Insulin 16965 (2016)16 China, Korea R, OL, non‐inferiority 24 weeks HbA1c ≥7.5 and ≤10.5%, FPG ≤6.7 mmol/L Insulin glargine, OADs LM25 East Asian (n = 40) Caucasian (n = 136) Insulin glargine + insulin lispro East Asian
Insulin 17033 and ≤10.5%, FPG ≤6.7 mmol/LInsulin glargine, OADs LM25 East Asian (n = 40) Caucasian (n = 136) Insulin glargine + insulin lispro East Asian (n = 40) Caucasian (n = 143) MET and/or PIO (all patients) LM25
Insulin 17249 breakfast & dinner (doses adjusted to achieve FBG or predinner plasma‐equivalent BG <6.1 mmol/L) Insulin glargine at bedtime (doses adjusted to achieve premeal plasma‐equivalent BG 5.6‐6.7 mmol/L) + insulin
Insulin 17598 non‐inferiority 24 weeks HbA1c ≥7.0 and ≤10.0%, and FPG <130 mg/dL on insulin glargine for ≥12 weeks Insulin glargine + OADs BIAsp30 (n = 83) Insulin glargine + insulin glulisine (n = 78) Continuation of OADs
Insulin 17639 ≤10.0%, and FPG <130 mg/dL on insulin glargine for ≥12 weeksInsulin glargine + OADs BIAsp30 (n = 83) Insulin glargine + insulin glulisine (n = 78) Continuation of OADs (all patients) BIAsp before breakfast &
Insulin 17801 OADs (all patients) BIAsp before breakfast & dinner (doses titrated to achieve FPG 70–100 mg/dL) Insulin glargine in evening (dose titrated to achieve FPG 70–100 mg/dL) + insulin glulisine before main meal
metformin 20252 protamine suspension; LM50 #bib50% insulin lispro #bib50% insulin lispro protamine suspension; MET, metformin ; NR, not reported; OADs, oral antihyperglycemic drugs; OL, open‐label; PIO, pioglitazone; PPG, postprandial
pioglitazone 19401 dosing not provided; §Comparator groups in this study included patients treated with exenatide or pioglitazone and were therefore not eligible for inclusion in this review; ¶Patients with glycated hemoglobin (HbA1c)
pioglitazone 20340 suspension; MET, metformin; NR, not reported; OADs, oral antihyperglycemic drugs; OL, open‐label; PIO, pioglitazone ; PPG, postprandial glucose; R, randomized; SU, sulfonylurea; TZD, thiazolidinediones.John Wiley & Sons,
Select Disease Character Offset Disease Term Instance
diabetes mellitus 7618 Asia (China; East Asia*; Hong Kong; Japan; Korea; Macao; Mongolia; Taiwan); and (iii) type 2 diabetes ( diabetes mellitus , type 2; non‐insulin dependent diabetes mellitus; T2D*; type 2 diabetes; type 2 diabetes mellitus).Where
diabetes mellitus 7669 Macao; Mongolia; Taiwan); and (iii) type 2 diabetes (diabetes mellitus, type 2; non‐insulin dependent diabetes mellitus ; T2D*; type 2 diabetes; type 2 diabetes mellitus).Where possible, search terms and strategies were individualized
diabetes mellitus 7718 (diabetes mellitus, type 2; non‐insulin dependent diabetes mellitus; T2D*; type 2 diabetes; type 2 diabetes mellitus ).Where possible, search terms and strategies were individualized to each database. Terms were combined
diabetes mellitus 8366 Taiwan [MeSH] OR China OR East Asia* OR Hong Kong OR Japan OR Korea OR Macao OR Mongolia OR Taiwan) AND ( diabetes mellitus , type 2 [MeSH] OR T2D* OR type 2 diabetes OR type 2 diabetes mellitus).There were no restrictions on
diabetes mellitus 8436 Macao OR Mongolia OR Taiwan) AND (diabetes mellitus, type 2 [MeSH] OR T2D* OR type 2 diabetes OR type 2 diabetes mellitus ).There were no restrictions on language.Study recordsSearches were collated using a bibliography manager,
hyperglycemia 3661 Furthermore, there are differences in glycemic indices and glycemic load related to diet, whereby postprandial hyperglycemia plays a more prominent role in modulating glycated hemoglobin (HbA1c) in Asians than Caucasians8, 9.
hypoglycemia 1614 glycated hemoglobin change from baseline to end‐point. The primary safety outcome was the incidence of hypoglycemia .ResultsA total of 21 studies were included; most (n = 14) were carried out in China or Japan. The duration
hypoglycemia 2041 (improvement was generally more pronounced with insulin initiation vs intensification). The incidence of hypoglycemia ranged from 8.3 to 72.0% in most studies, with the variability reflecting the definition of hypoglycemia
hypoglycemia 2146 hypoglycemia ranged from 8.3 to 72.0% in most studies, with the variability reflecting the definition of hypoglycemia used. Efficacy and safety outcomes for premixed insulin analogs were generally similar to those for
hypoglycemia 6442 (FPG), self‐monitoring of blood/plasma glucose (SMBG/SMPG) and insulin dose. Safety outcomes were hypoglycemia and bodyweight/BMI.SettingStudies carried out in East Asian countries/regions (China, Hong Kong, Japan,
hypoglycemia 9501 end‐point, and total daily insulin dose at study end‐point.The primary safety outcome was the incidence of hypoglycemia . The secondary outcome was the rate of hypoglycemia and bodyweight/BMI change from baseline.Risk of
hypoglycemia 9553 end‐point.The primary safety outcome was the incidence of hypoglycemia. The secondary outcome was the rate of hypoglycemia and bodyweight/BMI change from baseline.Risk of biasEach study was rated as having a low, high or unclear
hypoglycemia 11283 and 2 h postprandial PG <180 mg/dL >10 days All doses titrated to achieve HbA1c <7.0% with minimal hypoglycemia NR Ji (2016)15 China, Korea R, OL 48 weeks HbA1c ≥7.0 and ≤11.0%, insulin naïveOADs LM25 East
hypoglycemia 13253 OADs (all patients) Once daily (doses titrated to achieve fasting glucose <6.1 mmol/L without significant hypoglycemia ) After 3 weeks, patients with glycated albumin ≤20% or who had major or frequent hypoglycemia switched
hypoglycemia 13349 significant hypoglycemia) After 3 weeks, patients with glycated albumin ≤20% or who had major or frequent hypoglycemia switched to twice‐daily BIAsp30 before breakfast and dinner (doses titrated to achieve fasting glucose
hypoglycemia 13541 to achieve fasting glucose 6.1 mmol/L and 2 h postprandial glucose of 10 mmol/L, without significant hypoglycemia ) Yonsei University College of Medicine Yang (2013)21 China, Japan R, OL 24 weeks HbA1c ≥7.0 and
hypoglycemia 16835 meal All doses titrated to achieve preprandial BG <6.1 mmol/L and 2 h postprandial BG <7.8 mmol/L without hypoglycemia Eli Lilly Jeong (2016)16 China, Korea R, OL, non‐inferiority 24 weeks HbA1c ≥7.5 and ≤10.5%,
hypoglycemia 23850 HbA1c targetsFBG/FPG change†SMBG/SMPG change†Total daily insulin dose at end‐pointDefinition of hypoglycemia IncidenceBodyweight/BMI change†Initiation of insulin therapy Masuda (2008)17 LM50 vs NPH insulin +
hypoglycemia 32140 change from the end of the induction period to the end of each treatment period. asympt, asymptomatic hypoglycemia ; BIAsp30 #bib30% soluble insulin aspart #bib70% protamine‐crystallized insulin aspart; BIAsp70 #bib70%
hypoglycemia 32875 glucose; SMBG, self‐monitored blood glucose; SMPG, self‐monitored plasma glucose; sympt, symptomatic hypoglycemia ; undoc, undocumented.John Wiley & Sons, LtdA total of 15 studies15, 16, 20, 21, 23, 24, 25, 26, 27,
hypoglycemia 35486 outcomesIn 14 studies15, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32 reporting data, the incidence of hypoglycemia was highly variable, ranging from 8.3 to 72.0% among all studies, 8.3 to 68.9% in studies where patients
hypoglycemia 35806 intensification of insulin therapy (Table 3). In one study comparing high and low mixtures30, the incidence of hypoglycemia was considerably higher, at up to 90%. The incidence of nocturnal hypoglycemia ranged from 0 to 47.2%
hypoglycemia 35885 mixtures30, the incidence of hypoglycemia was considerably higher, at up to 90%. The incidence of nocturnal hypoglycemia ranged from 0 to 47.2% among all studies. Severe/major hypoglycemia, where reported, was rare, ranging
hypoglycemia 35953 90%. The incidence of nocturnal hypoglycemia ranged from 0 to 47.2% among all studies. Severe/major hypoglycemia , where reported, was rare, ranging from 0 to 7% among all studies (0% in most studies). Unsurprisingly,
hypoglycemia 36087 rare, ranging from 0 to 7% among all studies (0% in most studies). Unsurprisingly, the incidence of hypoglycemia was generally much higher in studies where assessment of hypoglycemia included undocumented hypoglycemia
hypoglycemia 36157 Unsurprisingly, the incidence of hypoglycemia was generally much higher in studies where assessment of hypoglycemia included undocumented hypoglycemia compared with studies where assessment only included documented hypoglycemia.In
hypoglycemia 36192 hypoglycemia was generally much higher in studies where assessment of hypoglycemia included undocumented hypoglycemia compared with studies where assessment only included documented hypoglycemia.In all but one17 of the
hypoglycemia 36269 included undocumented hypoglycemia compared with studies where assessment only included documented hypoglycemia .In all but one17 of the 14 studies15, 16, 17, 20, 21, 22, 23, 24, 25, 27, 28, 29, 30, 32 reporting data,
hypoglycemia 37658 insulin on the basis of the HbA1c change from baseline. Other outcomes, including the incidence of hypoglycemia , were not significantly different between the two treatment groups.Premixed insulin analogs vs Basal–bolus
hypoglycemia 38334 group compared with the basal–bolus group.16 Likewise, other outcomes, including the incidence of hypoglycemia and weight/BMI gain, were not significantly different between groups (or favored the premixed insulin
hypoglycemia 38934 the change from baseline in HbA1c was numerically similar between groups; however, the incidence of hypoglycemia was numerically lower in the premixed insulin analog group compared with the premixed human insulin
hypoglycemia 39791 Caucasians), total daily insulin dose (lower in East Asians), the overall and nocturnal incidence of hypoglycemia (lower in East Asians), and bodyweight gain (lower in East Asians). In the study reported by Jeong et
hypoglycemia 40332 East Asians), total daily insulin dose (lower in East Asians), the overall and nocturnal incidence of hypoglycemia (lower in East Asians), and bodyweight gain (lower in East Asians).DiscussionThis is the first systematic
hypoglycemia 42135 studies comparing premixed insulin analogs with other insulin treatments showed that the incidence of hypoglycemia and bodyweight/BMI gain were generally numerically similar between groups. These findings suggest that
hypoglycemia 42481 type 2 diabetes. The findings from several studies involving primarily Caucasian populations show that hypoglycemia is more common with twice‐daily premixed insulin than with basal insulin36, 37, 38. None of the studies
hypoglycemia 42783 additional studies are required to determine if twice‐daily premixed insulin increases the rate of hypoglycemia relative to basal insulin in East Asians with type 2 diabetes. Nevertheless, from the available evidence,
hypoglycemia 44178 premixed insulin analogs. Specifically, total daily insulin dose, the overall and nocturnal incidence of hypoglycemia , and bodyweight gain were lower in East Asians than in Caucasians treated with premixed insulin analogs.
hypoglycemia 44827 least in part explained by differences in dose between East Asians and Caucasians (e.g., those for hypoglycemia and bodyweight); however, race/ethnicity‐related factors cannot be ruled out, and, therefore, might
hypoglycemia 46599 diabetes. A pan‐Asian study of patients with type 2 diabetes showed that changes in HbA1c and rates of hypoglycemia after 26 weeks of treatment with BIAsp or insulin degludec/insulin aspart were not significantly different
type 2 diabetes mellitus 7711 diabetes (diabetes mellitus, type 2; non‐insulin dependent diabetes mellitus; T2D*; type 2 diabetes; type 2 diabetes mellitus ).Where possible, search terms and strategies were individualized to each database. Terms were combined
type 2 diabetes mellitus 8429 OR Macao OR Mongolia OR Taiwan) AND (diabetes mellitus, type 2 [MeSH] OR T2D* OR type 2 diabetes OR type 2 diabetes mellitus ).There were no restrictions on language.Study recordsSearches were collated using a bibliography manager,

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