title: Glargine insulin/gliclazide MR combination therapy is more effective than premixed insulin monotherapy in Chinese patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs.
abstract: BACKGROUND
  The aim of this study is to compare the efficacy and safety of once-daily insulin glargine plus gliclazide modified release combination therapy versus twice-daily premixed insulin monotherapy in Chinese type 2 diabetic patients insufficiently controlled by oral antidiabetic agents.
  
  
  METHODS
  In a 12-week, multicenter, randomized, parallel-group clinical trial, patients with poor glycaemic control (fasting plasma glucose ≥ 7.0 mmol/L and 7.5% < haemoglobin A1c  ≤ 10%) on oral antidiabetic drugs were randomized to the treatment groups for combination therapy (n = 52) or monotherapy (n = 53). Continuous glucose monitoring was carried out over two 72-h periods, at the beginning and the end of the study, and the data were used to calculate the 24-h mean blood glucose, mean amplitude of glycaemic excursions, standard deviation of blood glucose, and the mean of daily differences.
  
  
  RESULTS
  The mean haemoglobin A1c decrease from baseline to study end was significant for both treatment groups (combination therapy: -1.23 ± 0.92%; insulin monotherapy: -1.02 ± 1.04%); moreover, the combination therapy group showed a significantly more robust haemoglobin A1c decrease (p = 0.0308). Both therapies significantly reduced the 24-h mean blood glucose (both, p < 0.001), but neither produced a significant effect on glycaemic variability, calculated as mean amplitude of glycaemic excursions, standard deviation of blood glucose, and mean of daily differences. In addition, the effects on rates of hypoglycaemic episodes were similar between the two therapies.
  
  
  CONCLUSIONS
  Chinese patients with type 2 diabetes inadequately controlled with oral antidiabetic agents attained greater benefit from once-daily insulin glargine plus gliclazide modified release regimen than from a twice-daily premixed insulin regimen.
authors.affiliation: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Zhou
authors.affiliation: Department of Endocrinology and Metabolism, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
authors.forename: Fenping
authors.initials: F
authors.lastname: Zheng
authors.affiliation: Department of Endocrinology and Metabolism, Peking University First Hospital, Beijing, China.
authors.forename: Xiaohui
authors.initials: X
authors.lastname: Guo
authors.affiliation: Department of Endocrinology and Metabolism, Guangdong General Hospital, Guangzhou, Guangdong, China.
authors.forename: Huazhang
authors.initials: H
authors.lastname: Yang
authors.affiliation: Department of Endocrinology and Metabolism, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Muxun
authors.initials: M
authors.lastname: Zhang
authors.affiliation: Department of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, China.
authors.forename: Haoming
authors.initials: H
authors.lastname: Tian
authors.affiliation: Department of Endocrinology and Metabolism, Beijing Hospital of Ministry of Public Health, Beijing, China.
authors.forename: Lixin
authors.initials: L
authors.lastname: Guo
authors.affiliation: Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China.
authors.forename: Yifei
authors.initials: Y
authors.lastname: Mo
authors.affiliation: Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China.
authors.forename: Weiping
authors.initials: W
authors.lastname: Jia
mesh_terms: D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D005907:Gliclazide / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D005907:Gliclazide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; C517652:hemoglobin A1c protein, human
keywords: continuous glucose monitoring; gliclazide MR; premixed insulin; type 2 diabetes