Insulin lispro 25/75 and insulin lispro 50/50 as starter insulin in Japanese patients with type 2 diabetes: subanalysis of the CLASSIFY randomized trial

In Japan, premixed insulins are commonly used as starter insulin for type 2 diabetes. This subpopulation analysis assessed the efficacy and safety of twice-daily LM25 (25% insulin lispro/75% insulin lispro protamine) and LM50 (50% insulin lispro/50% insulin lispro protamine) as starter insulin in Ja...

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Veröffentlicht in:Endocrine Journal 2017, Vol.64(7), pp.705-717
Hauptverfasser: Watada, Hirotaka, Imori, Makoto, Li, Pengfei, Iwamoto, Noriyuki
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creator Watada, Hirotaka
Imori, Makoto
Li, Pengfei
Iwamoto, Noriyuki
description In Japan, premixed insulins are commonly used as starter insulin for type 2 diabetes. This subpopulation analysis assessed the efficacy and safety of twice-daily LM25 (25% insulin lispro/75% insulin lispro protamine) and LM50 (50% insulin lispro/50% insulin lispro protamine) as starter insulin in Japanese subjects, and compared these results with the whole-trial populations of East Asian subjects. In this subpopulation analysis of an open-label, phase 4, randomized trial (CLASSIFY), Japanese subjects received LM25 (n = 88) or LM50 (n = 84) twice-daily for 26 weeks. The primary outcome was change from baseline at Week 26 in glycated hemoglobin (HbA1c). Results for Japanese subjects were generally similar to those for the whole-trial population. Similar changes from baseline in HbA1c were observed for LM25 and LM50 groups (least squares [LS] mean difference [95% confidence interval] of LM25 - LM50 = 0.13 [-0.16, 0.41]%, 1.42 [-1.75, 4.48] mmol/mol, p = 0.388). More LM50-treated subjects than LM25-treated subjects achieved HbA1c targets of
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This subpopulation analysis assessed the efficacy and safety of twice-daily LM25 (25% insulin lispro/75% insulin lispro protamine) and LM50 (50% insulin lispro/50% insulin lispro protamine) as starter insulin in Japanese subjects, and compared these results with the whole-trial populations of East Asian subjects. In this subpopulation analysis of an open-label, phase 4, randomized trial (CLASSIFY), Japanese subjects received LM25 (n = 88) or LM50 (n = 84) twice-daily for 26 weeks. The primary outcome was change from baseline at Week 26 in glycated hemoglobin (HbA1c). Results for Japanese subjects were generally similar to those for the whole-trial population. Similar changes from baseline in HbA1c were observed for LM25 and LM50 groups (least squares [LS] mean difference [95% confidence interval] of LM25 - LM50 = 0.13 [-0.16, 0.41]%, 1.42 [-1.75, 4.48] mmol/mol, p = 0.388). More LM50-treated subjects than LM25-treated subjects achieved HbA1c targets of &lt;7.0% (59.5% versus 43.2%; p = 0.034) or ≤6.5% (45.2% versus 28.4%; p = 0.027). The reduction in postprandial blood glucose concentrations after morning and evening meals was statistically significantly greater for LM50 than for LM25. The incidence of both hypoglycemia and treatment-emergent adverse events were similar between treatment groups. 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Imori, Makoto ; Li, Pengfei ; Iwamoto, Noriyuki</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c526t-be17b8e51da0213534c8d1d8515e9f296b44cdbb011cb2af85f7d9ee052652173</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Aged</topic><topic>Asian Continental Ancestry Group</topic><topic>Biphasic Insulins - administration &amp; dosage</topic><topic>Biphasic Insulins - adverse effects</topic><topic>Biphasic Insulins - therapeutic use</topic><topic>Blood glucose</topic><topic>Blood Glucose - analysis</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - ethnology</topic><topic>Drug Administration Schedule</topic><topic>Far East - epidemiology</topic><topic>Female</topic><topic>Glucose</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>Hemoglobin</topic><topic>Humans</topic><topic>Hyperglycemia - prevention &amp; 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This subpopulation analysis assessed the efficacy and safety of twice-daily LM25 (25% insulin lispro/75% insulin lispro protamine) and LM50 (50% insulin lispro/50% insulin lispro protamine) as starter insulin in Japanese subjects, and compared these results with the whole-trial populations of East Asian subjects. In this subpopulation analysis of an open-label, phase 4, randomized trial (CLASSIFY), Japanese subjects received LM25 (n = 88) or LM50 (n = 84) twice-daily for 26 weeks. The primary outcome was change from baseline at Week 26 in glycated hemoglobin (HbA1c). Results for Japanese subjects were generally similar to those for the whole-trial population. Similar changes from baseline in HbA1c were observed for LM25 and LM50 groups (least squares [LS] mean difference [95% confidence interval] of LM25 - LM50 = 0.13 [-0.16, 0.41]%, 1.42 [-1.75, 4.48] mmol/mol, p = 0.388). More LM50-treated subjects than LM25-treated subjects achieved HbA1c targets of &lt;7.0% (59.5% versus 43.2%; p = 0.034) or ≤6.5% (45.2% versus 28.4%; p = 0.027). The reduction in postprandial blood glucose concentrations after morning and evening meals was statistically significantly greater for LM50 than for LM25. The incidence of both hypoglycemia and treatment-emergent adverse events were similar between treatment groups. Both LM25 and LM50 twice daily appear to be effective and well tolerated as starter insulin, although LM50 might be more effective for Japanese type 2 diabetes patients.</abstract><cop>Japan</cop><pub>The Japan Endocrine Society</pub><pmid>28539526</pmid><doi>10.1507/endocrj.EJ17-0020</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Asian Continental Ancestry Group
Biphasic Insulins - administration & dosage
Biphasic Insulins - adverse effects
Biphasic Insulins - therapeutic use
Blood glucose
Blood Glucose - analysis
Diabetes
Diabetes mellitus
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - ethnology
Drug Administration Schedule
Far East - epidemiology
Female
Glucose
Glycated Hemoglobin A - analysis
Hemoglobin
Humans
Hyperglycemia - prevention & control
Hypoglycemia
Hypoglycemia - chemically induced
Hypoglycemia - epidemiology
Hypoglycemia - prevention & control
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - adverse effects
Hypoglycemic Agents - therapeutic use
Incidence
Insulin
Insulin lispro
Insulin Lispro - administration & dosage
Insulin Lispro - adverse effects
Insulin Lispro - therapeutic use
Insulin Resistance - ethnology
Insulin, Isophane - administration & dosage
Insulin, Isophane - adverse effects
Insulin, Isophane - therapeutic use
Japan
Japan - epidemiology
Male
Middle Aged
Patients
Postprandial Period
Premixed insulin
Protamine
title Insulin lispro 25/75 and insulin lispro 50/50 as starter insulin in Japanese patients with type 2 diabetes: subanalysis of the CLASSIFY randomized trial
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