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 CGMSIncidence 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
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