title: Comparison of insulin lispro mix 25 with insulin lispro mix 50 as insulin starter in Chinese patients with type 2 diabetes mellitus (CLASSIFY study): Subgroup analysis of a Phase 4 open-label randomized trial.
abstract: BACKGROUND
  Premixed insulins are recommended starter insulins in Chinese patients after oral antihyperglycemic medication (OAM) failure. In the present study, we compared the efficacy and safety of insulin lispro mix 25 (LM25) twice daily (b.i.d.) and insulin lispro mix 50 (LM50) b.i.d. as a starter insulin regimen in Chinese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with OAMs.
  
  
  METHODS
  The primary efficacy outcome in the present open-label parallel randomized clinical trial was change in HbA1c from baseline to 26 weeks. Patients were randomized in a ratio of 1:  1 to LM25 (n = 80) or LM50 (n = 76). A mixed-effects model with repeated measures was used to analyze continuous variables. The Cochran-Mantel-Haenszel test with stratification factor was used to analyze categorical variables.
  
  
  RESULTS
  At the end of the study, LM50 was more efficacious than LM25 in reducing mean HbA1c levels (least-squares [LS] mean difference 0.48; 95 % confidence interval [CI] 0.22, 0.74; P < 0.001). More subjects in the LM50 than LM25 group achieved HbA1c targets of <7.0 % (72.4 % vs 45.0 %; P = 0.001) or ≤6.5 % (52.6 % vs 20.0 %; P < 0.001). Furthermore, LM50 was more effective than LM25 at reducing HbA1c in patients with baseline HbA1c, blood glucose excursion, and postprandial glucose greater than or equal to median levels (P ≤ 0.001). The rate and incidence of hypoglycemic episodes and increase in weight at the end of the study were similar between treatment groups.
  
  
  CONCLUSIONS
  In Chinese patients with T2DM, LM50 was more efficacious than LM25 as a starter insulin.
authors.affiliation: Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Su
authors.affiliation: Department of Endocrinology, Affiliated Hospital on Integration of Chinese and Western Medicine, Nanjing University of Chinese Medicine, Jiangsu Province Academy of Traditional Chinese Medicine, Nanjing, China.
authors.forename: Chao
authors.initials: C
authors.lastname: Liu
authors.affiliation: Department of Endocrinology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Hongting
authors.initials: H
authors.lastname: Zheng
authors.affiliation: Xinjiang Key Laboratory of Metabolic Disease Research, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zhu
authors.affiliation: Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.
authors.forename: Peng Fei
authors.initials: PF
authors.lastname: Li
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 and Metabolism, China-Japan Friendship Hospital, Beijing, China.
authors.forename: Wen Ying
authors.initials: WY
authors.lastname: Yang
mesh_terms: D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy* / Q000208:ethnology; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000737:chemistry / Q000627:therapeutic use; D061268:Insulin Lispro / Q000737:chemistry / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019518:Postprandial Period; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061268:Insulin Lispro
keywords: China; diabetes mellitus; glycated hemoglobin; mixed insulins; postprandial hyperglycemia; 中国; 糖化血红蛋白; 糖尿病; 预混胰岛素; 餐后高血糖