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.

Keywords::

• Glimepiride
• Initial treatment
• Type 2 diabetes mellitus

Transparency

Declaration of funding

This study was funded by Sanofi (China) Investment Co. Ltd.

Declaration of financial/other relationships

The authors of this manuscript have disclosed receiving sponsorship from Sanofi to conduct this study. They have no other relevant financial relationships to disclose.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors would like to thank the investigators of this study: Sheng-li Yan (The Affiliated Hospital of Medical College Qingdao University, China), Zhong-yan Shan (The First Hospital of China Medical University, China), Qing Su (Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, China), Li-ming Chen (Tianjin Medical University Metabolic Diseases Hospital, China), Jian-ling Du (First Affiliated Hospital of Dalian Medical University, China;), Qin-hua Song (The Affiliated Hospital of Hainan Medical College, China), Yong-de Peng (First People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, China), Xing-bo Cheng (The First Affiliated Hospital of Soochow University, China), Qi-fu Li (The first Affiliated Hospital, Chongqing Medical University, China), Hao-ming Tian (West China Hospital, Sichuan University, China), Jian Wang (Nanjing General Hospital of Nanjing Military Command, China), Qiu-he Ji (Xijing Hospital affiliated to The Fourth Military Medical University, China). The authors also thank Cunnan Dong for writing support, Zheng Gu, Shuhua Shang, Ming Yang and Shenghong Gu for critical revision, and Sam Zhong for statistical support. The authors thank every individual from many institutions that participated to complete this study.

Previous presentation: The data from this manuscript have been presented as abstract and poster in the International Diabetes Federation (IDF) Congress, 4–8 December 2011, Dubai.