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

Information source: Servier (Tianjin) Pharmaceutical Co. LTD.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Gliclazide MR and Insulin Glargine Injection (Drug); Biosynthetic Human Insulin Injection (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Servier (Tianjin) Pharmaceutical Co. LTD.

Official(s) and/or principal investigator(s):
Weiping Jia, MD, PHD, Principal Investigator, Affiliation: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Jian Zhou, MD, PHD, Study Director, Affiliation: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Yuqian Bao, MD, PHD, Study Director, Affiliation: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Huazhang Yang, MD, PHD, Study Director, Affiliation: Guangdong General Hospital
Jian Kuang, MD, PHD, Study Director, Affiliation: Guangdong General Hospital
Hongmei Chen, MD, Study Director, Affiliation: Guangdong General Hospital
Haoming Tian, MD, Study Director, Affiliation: West China Hospital
Hong Li, MD, Study Director, Affiliation: SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine
Fenping Zheng, MD, Study Director, Affiliation: SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine
Qiang Li, MD, Study Director, Affiliation: The Second Affiliated Hospital of Harbin Medical University
Xiaohui Guo, MD, PHD, Study Director, Affiliation: Peking University First Hospital
Ying Gao, MD, PHD, Study Director, Affiliation: Peking University First Hospital
Muxun Zhang, MD, Study Director, Affiliation: Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology
Lixin Guo, MD, PHD, Study Director, Affiliation: Beijing Hospital
Yan Ren, MD, PHD, Study Director, Affiliation: West China Hospital

Overall contact:
Veronica Wang, MD, Phone: 0086-10-65610341, Ext: 237, Email: veronica.wang@cn.netgrs.com

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.

Clinical Details

Official title: Phase 4 Study of Comparison of Combination Therapy of Gliclazide MR and Basal Insulin With Pre-mix Insulin Monotherapy for the Patients With Type 2 Diabetes Mellitus

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG

Secondary outcome:

MBG, SDBG, MAGE and MODD in the 48th CGMS

Incidence of hypoglycemia and severe hypoglycemia

Weight change

Detailed description: Inclusion criteria: 1. Male or female with type 2 diabetes mellitus 2. 35 years old≤age≤65 years old 3. 19kg/m2≤BMI≤32kg/m2 4. Uncontrolled blood glycemia (FPG≥7. 0mmol/L and 7. 5%

Eligibility

Minimum age: 35 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion criteria: 1. Male or female with type 2 diabetes mellitus 2. 35 years old≤age≤65 years old 3. 19kg/m2≤BMI≤32kg/m2 4. Uncontrolled blood glycemia (FPG≥7. 0mmol/L and 7. 5%

Locations and Contacts

Veronica Wang, MD, Phone: 0086-10-65610341, Ext: 237, Email: veronica.wang@cn.netgrs.com

Beijing Hospital, Beijing, Beijing 100730, China; Recruiting
Qinghua He, MD, Email: heqinghuar@sina.com
Lixin Guo, MD, PHD, Principal Investigator

Peking University First Hospital, Beijing, Beijing 100034, China; Recruiting
Ying Gao, MD, PHD, Email: bjgaoying@yahoo.com
Xiaohui Guo, MD, PHD, Principal Investigator

Guangdong General Hospital, Guangzhou, Guangdong 510080, China; Recruiting
Hongmei Chen, MD, Email: ch_may@163.com
Jian Kuang, MD, PHD, Email: kuang_jian@hotmail.com
Huazhang Yang, MD, PHD, Principal Investigator

The 2nd Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150086, China; Suspended

Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology, Wuhan, Hubei 430030, China; Terminated

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai 200233, China; Recruiting
Jian Zhou, MD, PHD, Email: zhoujian8337@126.com
Yuqian Bao, MD, PHD, Email: byq522@126.com
Weiping Jia, MD, PHD, Principal Investigator

West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China; Terminated

SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou, Zhejiang 310016, China; Completed

Additional Information

Related publications:

Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Järvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care. 2005 Feb;28(2):254-9.

Starting date: October 2008
Last updated: August 19, 2010

Page last updated: August 23, 2015

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