title: Efficacy and safety of glimepiride as initial treatment in Chinese patients with Type 2 diabetes mellitus.
abstract: OBJECTIVE
  To investigate the efficacy and safety of glimepiride as initial mono-therapy in type 2 diabetes patients in China.
  
  
  METHODS
  This is a multi-center, open-label, single arm study. A total of 391 subjects were enrolled to receive glimepiride treatment for 16 weeks, the initiation dose was 1 mg/d, with titration to 2 mg/d and 4 mg/d according to the fasting blood glucose (FBG) level measured at each visit. The change in HbA1c, fasting plasma glucose (FPG), 2 h postprandial blood glucose (2hPPG), HOMA-IR, weight, waist circumference and the incidence of hypoglycemia were evaluated. An exploratory analysis was conducted to identify the potential population prone to achieve target glycemic control.
  
  
  RESULTS
  HbA1c was reduced significantly from 8.6 ± 1.6% to 6.9 ± 0.9% (p < 0.001); 60.9% of the subjects achieved HbA1c <7% at study endpoint. The reduction in FPG and 2hPPG were 2.3 mmol/L and 4.4 mmol/L (p < 0.001) respectively. Insulin resistance was improved significantly with HOMA-IR decreasing from 2.5 ± 2.3 to 2.2 ± 1.9 (p = 0.009). The incidence of confirmed hypoglycemia (BG ≤ 3.9 mmol/L) was 3.1%.
  
  
  CONCLUSIONS
  Glimepiride treatment as initial mono-therapy could effectively improve blood glucose control in type 2 diabetic patients, with a favorable safety profile. Lack of control group was the major limitation of this study. ClinicalTrial.gov identifier: NCT00908921.
authors.affiliation: Peking University First Hospital, Beijing, China.
authors.forename: Xiao-Hui
authors.initials: XH
authors.lastname: Guo
authors.forename: Xiao-Feng
authors.initials: XF
authors.lastname: Lv
authors.forename: Ping
authors.initials: P
authors.lastname: Han
authors.forename: Xiu-Zhen
authors.initials: XZ
authors.lastname: Zhang
authors.forename: Hua-Zhang
authors.initials: HZ
authors.lastname: Yang
authors.forename: Wen-Ruo
authors.initials: WR
authors.lastname: Duan
authors.forename: Yan
authors.initials: Y
authors.lastname: Gao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight; D002681:China / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000188:drug therapy / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D015994:Incidence; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D013453:Sulfonylurea Compounds / Q000009:adverse effects* / Q000627:therapeutic use*; D016896:Treatment Outcome; D055105:Waist Circumference; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; C517652:hemoglobin A1c protein, human; C057619:glimepiride