Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes

Summary

In recent years, with the further research of the pathogenesis of diabetes mellitus and the mechanism of oral antidiabetes drugs, the early combination therapy of oral antidiabetes drugs and insulin is getting paid more and more attention. A lot of studies have confirmed that Gliclazide MRs have excellent reducing blood glucose efficacy and vascular protection. Based on these theory and practice, this study is designed to demonstrate whether the combination therapy of Gliclazide MR and basal insulin can control the blood glycemia effectively and reduce the dosage of insulin and the hypoglycemia events compared to the premix insulin monotherapy.

Conditions

• Type 2 Diabetes

Interventions

DRUG

Gliclazide MR and Insulin Glargine Injection

Combination therapy of oral administration of 60-120mg Gliclazide Modified Release Tablet once daily before breakfast and subcutaneous injection of Insulin Glargine Injection once daily before dinner (initial dosage 0.2U/KG/D) for 3 months

DRUG

Biosynthetic Human Insulin Injection

Monotherapy of subcutaneous injection of Biosynthetic Human Insulin Injection twice daily (before breakfast and before dinner) (initial dosage 0.4-0.6U/KG/D) for 3 months

Sponsors & Collaborators

• Servier (Tianjin) Pharmaceutical Co. LTD.

  lead INDUSTRY

Principal Investigators

• Weiping Jia, MD, PHD · Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

• Jian Zhou, MD, PHD · Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

• Yuqian Bao, MD, PHD · Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

• Huazhang Yang, MD, PHD · Guangdong Provincial People's Hospital

• Jian Kuang, MD, PHD · Guangdong Provincial People's Hospital

• Hongmei Chen, MD · Guangdong Provincial People's Hospital

• Haoming Tian, MD · West China Hospital

• Hong Li, MD · SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine

• Fenping Zheng, MD · SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine

• Qiang Li, MD · The Second Affiliated Hospital of Harbin Medical University

• Xiaohui Guo, MD, PHD · Peking University First Hospital

• Ying Gao, MD, PHD · Peking University First Hospital

• Muxun Zhang, MD · Tongji Hospital

• Lixin Guo, MD, PHD · Beijing Hospital

• Yan Ren, MD, PHD · West China Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2011-08-31

Completion

2011-08-31

Countries

• China

Study Locations