Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes (CODMS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Servier (Tianjin) Pharmaceutical Co. LTD..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Servier (Tianjin) Pharmaceutical Co. LTD.
Information provided by:
Servier (Tianjin) Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT00736515
First received: August 15, 2008
Last updated: August 19, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Gliclazide MR and Insulin Glargine Injection Drug: Biosynthetic Human Insulin Injection |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Servier (Tianjin) Pharmaceutical Co. LTD.:
Primary Outcome Measures:
- Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- MBG, SDBG, MAGE and MODD in the 48th CGMS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Incidence of hypoglycemia and severe hypoglycemia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Weight change [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combination therapy
The subjects allocated into this arm will receive the combination therapy of oral administration of 60~120mg Gliclazide MR (Diamicron MR) and subcutaneous injection of basal insulin (Insulin Glargine Injection, Lantus) once daily for 3 months
|
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
Other Name: Brand Name: Diamicron MR and Lantus
|
|
Active Comparator: monotherapy
The patients allocated into this arm will receive the monotherapy of subcutaneous injection of premixed insulin (Biosynthetic Human Insulin Injection, Novolin 30R) twice daily 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
Other Name: Brand Name: Novolin 30R
|
Detailed Description:
Inclusion criteria:
- Male or female with type 2 diabetes mellitus
- 35 years old≤age≤65 years old
- 19kg/m2≤BMI≤32kg/m2
- Uncontrolled blood glycemia (FPG≥7.0mmol/L and 7.5%<HbA1c≤10%) after oral antidiabetes drugs treatment for more than 3 months
- Treated by diet controlling, 1 secretagogue agent and another oral antidiabetes drug, with the daily dosage of the secretagogue agent not more than 50% of its maximum
- Not participated in other clinical studies within the past 3 months
- Well know this study and sign the informed consent form
Exclusion criteria:
- Unable to sign the informed consent form
- Treated by insulin, even transient usage within the past 1 year
- Type 1 diabetes mellitus
- Abnormal condition of gastrointestinal tract against the absorption of oral drugs
- Insufficient of liver and kidney function: ALT≥2.5 times of the upper limit of the normal value range and serum creatinine≥the upper limit of the normal value range
- Encountered the cardiovascular events such as the angina pectoris, myocardial infarction, severe ventricular arrhythmia, cerebral hemorrhage, cerebral infarction, heart failure ect. within the past half year
- Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months
- psychotic
- Allergic history to sulfonylurea drugs
- Diabetic coma or diabetic ketoacidosis
- In use of the miconazole
- Pregnancy or breeding women
Primary endpoint:
Decreasing value of FPG and HbA1c, Dosage of the insulin, Control rate of FPG
Second Endpoints:
- MBG, SDBG, MAGE and MODD in the 48th CGMS
- Incidence of hypoglycemia and severe hypoglycemia
- Weight change
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Male or female with type 2 diabetes mellitus
- 35 years old≤age≤65 years old
- 19kg/m2≤BMI≤32kg/m2
- Uncontrolled blood glycemia (FPG≥7.0mmol/L and 7.5%<HbA1c≤10%) after oral antidiabetes drugs treatment for more than 3 months
- Treated by diet controlling, 1 secretagogue agent and another oral antidiabetes drug, with the daily dosage of the secretagogue agent not more than 50% of its maximum
- Not participated in other clinical studies within the past 3 months
- Well know this study and sign the informed consent form
Exclusion criteria:
- Unable to sign the informed consent form
- Treated by insulin, even transient usage within the past 1 year
- Type 1 diabetes mellitus
- Abnormal condition of gastrointestinal tract against the absorption of oral drugs
- Insufficient of liver and kidney function: ALT≥2.5 times of the upper limit of the normal value range and serum creatinine≥the upper limit of the normal value range
- Encountered the cardiovascular events such as the angina pectoris, myocardial infarction, severe ventricular arrhythmia, cerebral hemorrhage, cerebral infarction, heart failure ect. within the past half year
- Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months
- psychotic
- Allergic history to sulfonylurea drugs
- Diabetic coma or diabetic ketoacidosis
- In use of the miconazole
- Pregnancy or breeding women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736515
Contacts
| Contact: Veronica Wang, MD | 0086-10-65610341 ext 237 | veronica.wang@cn.netgrs.com |
| Contact: Jian Zhou, MD, PHD | 0086-10-64369181 | zhoujian8337@126.com |
Locations
| China, Beijing | |
| Peking University First Hospital | Recruiting |
| Beijing, Beijing, China, 100034 | |
| Contact: Ying Gao, MD, PHD bjgaoying@yahoo.com | |
| Principal Investigator: Xiaohui Guo, MD, PHD | |
| Beijing Hospital | Recruiting |
| Beijing, Beijing, China, 100730 | |
| Contact: Qinghua He, MD heqinghuar@sina.com | |
| Principal Investigator: Lixin Guo, MD, PHD | |
| China, Guangdong | |
| Guangdong General Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510080 | |
| Contact: Hongmei Chen, MD ch_may@163.com | |
| Contact: Jian Kuang, MD, PHD kuang_jian@hotmail.com | |
| Principal Investigator: Huazhang Yang, MD, PHD | |
| China, Heilongjiang | |
| The 2nd Affiliated Hospital of Harbin Medical University | Suspended |
| Harbin, Heilongjiang, China, 150086 | |
| China, Hubei | |
| Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology | Terminated |
| Wuhan, Hubei, China, 430030 | |
| China, Shanghai | |
| Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Recruiting |
| Shanghai, Shanghai, China, 200233 | |
| Contact: Jian Zhou, MD, PHD zhoujian8337@126.com | |
| Contact: Yuqian Bao, MD, PHD byq522@126.com | |
| Principal Investigator: Weiping Jia, MD, PHD | |
| China, Sichuan | |
| West China Hospital of Sichuan University | Terminated |
| Chengdu, Sichuan, China, 610041 | |
| China, Zhejiang | |
| SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine | Completed |
| Hangzhou, Zhejiang, China, 310016 | |
Sponsors and Collaborators
Servier (Tianjin) Pharmaceutical Co. LTD.
Investigators
| Principal Investigator: | Weiping Jia, MD, PHD | Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
| Study Director: | Jian Zhou, MD, PHD | Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
| Study Director: | Yuqian Bao, MD, PHD | Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
| Study Director: | Huazhang Yang, MD, PHD | Guangdong General Hospital |
| Study Director: | Jian Kuang, MD, PHD | Guangdong General Hospital |
| Study Director: | Hongmei Chen, MD | Guangdong General Hospital |
| Study Director: | Haoming Tian, MD | West China Hospital |
| Study Director: | Hong Li, MD | SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine |
| Study Director: | Fenping Zheng, MD | SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine |
| Study Director: | Qiang Li, MD | The 2nd affiliated hospital of harbin medical university |
| Study Director: | Xiaohui Guo, MD, PHD | Peking University First Hospital |
| Study Director: | Ying Gao, MD, PHD | Peking University First Hospital |
| Study Director: | Muxun Zhang, MD | Huazhong University of Science and Technology |
| Study Director: | Lixin Guo, MD, PHD | Beijing Hospital |
| Study Director: | Yan Ren, MD, PHD | West China Hospital |
More Information
Publications:
| Responsible Party: | Veronica Wang / Scientific Project Leader, Marketing Department in Servier (Tianjin) Pharmaceutical Co. LTD |
| ClinicalTrials.gov Identifier: | NCT00736515 History of Changes |
| Other Study ID Numbers: | IC4-5702-205-CHN |
| Study First Received: | August 15, 2008 |
| Last Updated: | August 19, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Servier (Tianjin) Pharmaceutical Co. LTD.:
|
combination therapy,monotherapy,gliclazide MR,insulin,CGMS |
Additional relevant MeSH terms:
|
Insulin Insulin, Long-Acting Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Glargine Gliclazide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013