- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00736515
Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes (CODMS)
March 29, 2020 updated by: Servier (Tianjin) Pharmaceutical Co. LTD.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100034
- Peking University First Hospital
-
Beijing, Beijing, China, 100730
- Beijing Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Guangdong General Hospital
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150086
- The 2nd Affiliated Hospital of Harbin Medical University
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
-
-
Shanghai
-
Shanghai, Shanghai, China, 200233
- Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- West China Hospital of Sichuan University
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MBG, SDBG, MAGE and MODD in the 48th CGMS
Time Frame: 3 months
|
3 months
|
Incidence of hypoglycemia and severe hypoglycemia
Time Frame: 3 months
|
3 months
|
Weight change
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Provincial People's Hospital
- Study Director: Jian Kuang, MD, PHD, Guangdong Provincial People's Hospital
- Study Director: Hongmei Chen, MD, Guangdong Provincial People's 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 Second 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, Tongji Hospital
- Study Director: Lixin Guo, MD, PHD, Beijing Hospital
- Study Director: Yan Ren, MD, PHD, West China Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Jarvinen 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. doi: 10.2337/diacare.28.2.254.
- Zhou J, Zheng F, Guo X, Yang H, Zhang M, Tian H, Guo L, Li Q, Mo Y, Jia W. Glargine insulin/gliclazide MR combination therapy is more effective than premixed insulin monotherapy in Chinese patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs. Diabetes Metab Res Rev. 2015 Oct;31(7):725-33. doi: 10.1002/dmrr.2661. Epub 2015 Jun 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
August 15, 2008
First Submitted That Met QC Criteria
August 15, 2008
First Posted (ESTIMATE)
August 18, 2008
Study Record Updates
Last Update Posted (ACTUAL)
April 3, 2020
Last Update Submitted That Met QC Criteria
March 29, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IC4-5702-205-CHN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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