title: Comparison of insulin lispro mix 25 with insulin lispro mix 50 as an insulin starter in Asian patients with type 2 diabetes: a phase 4, open-label, randomized trial (CLASSIFY study).
abstract: Lispro Mix 25% insulin lispro/75% insulin lispro protamine (LM25) and Lispro Mix 50% insulin lispro/50% insulin lispro protamine (LM50) were compared as starter insulins in East Asian patients with type 2 diabetes.
  
  
  
  Phase 4, open-label, randomized trial conducted in China, Japan, Korea, and Turkey. Subjects received twice-daily LM25 (n = 207) or LM50 (n = 196) for 26 weeks. The primary outcome was the HbA1cchange from baseline.
  
  
  
  The least squares mean changes from baseline in HbA1care -1.52% and -1.69% for LM25 and LM50, respectively, and the least squares mean difference [95% CI] is 0.17% [-0.01, 0.35]. More subjects in the LM50 group than in the LM25 group achieved HbA1ctargets of <7.0% (59.7% versus 45.9%, respectively; p = 0.007). LM50 was more effective than LM25 in reducing postprandial glucose after the morning (mean difference in change from baseline, 0.56 mmol/L; p = 0.038) and evening (1.11 mmol/L; p < 0.001) meals. The reduction in fasting blood glucose was significantly greater (p = 0.046) in the LM25 group (LS mean [95% CI] change from baseline: -2.37 mmol/L [-2.68, -2.06]) than in the LM50 group (-1.99 mmol/L [-2.30, -1.68]). LM50 was more effective than LM25 in reducing HbA1cin subjects with baseline HbA1c, postprandial glucose, or carbohydrate intake levels greater than the median levels. Hypoglycemia rates and weight gain were similar between groups.
  
  
  
  LM25 and LM50 were noninferior to each other in improving glycemic control in Asian patients with type 2 diabetes. In addition, LM50 was more efficacious than LM25 with respect to the percentage of subjects reaching target HbA1clevels. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Watada
authors.affiliation: Department of Endocrinology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Su
authors.affiliation: Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.
authors.forename: Peng Fei
authors.initials: PF
authors.lastname: Li
authors.affiliation: Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Iwamoto
authors.affiliation: Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Qian
authors.affiliation: Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
authors.forename: Wen Ying
authors.initials: WY
authors.lastname: Yang
mesh_terms: D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D005202:Asia, Eastern / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D061268:Insulin Lispro / Q000627:therapeutic use*; D007390:International Agencies; D008297:Male; D008875:Middle Aged; D011379:Prognosis
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061268:Insulin Lispro; C517652:hemoglobin A1c protein, human
keywords: Asian population; T2DM; postprandial blood glucose; premix insulin