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

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ClinicalTrials.gov Identifier: NCT00736515
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Servier (Tianjin) Pharmaceutical Co. LTD.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Gliclazide MR and Insulin Glargine Injection Drug: Biosynthetic Human Insulin Injection Phase 4

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%<HbA1c≤10%) after oral antidiabetes drugs treatment for more than 3 months
  5. 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
  6. Not participated in other clinical studies within the past 3 months
  7. Well know this study and sign the informed consent form

Exclusion criteria:

  1. Unable to sign the informed consent form
  2. Treated by insulin, even transient usage within the past 1 year
  3. Type 1 diabetes mellitus
  4. Abnormal condition of gastrointestinal tract against the absorption of oral drugs
  5. 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
  6. 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
  7. Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months
  8. psychotic
  9. Allergic history to sulfonylurea drugs
  10. Diabetic coma or diabetic ketoacidosis
  11. In use of the miconazole
  12. Pregnancy or breeding women

Primary endpoint:

Decreasing value of FPG and HbA1c, Dosage of the insulin, Control rate of FPG

Second Endpoints:

  1. MBG, SDBG, MAGE and MODD in the 48th CGMS
  2. Incidence of hypoglycemia and severe hypoglycemia
  3. Weight change
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. MBG, SDBG, MAGE and MODD in the 48th CGMS [ Time Frame: 3 months ]
  2. Incidence of hypoglycemia and severe hypoglycemia [ Time Frame: 3 months ]
  3. Weight change [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%<HbA1c≤10%) after oral antidiabetes drugs treatment for more than 3 months
  5. 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
  6. Not participated in other clinical studies within the past 3 months
  7. Well know this study and sign the informed consent form

Exclusion criteria:

  1. Unable to sign the informed consent form
  2. Treated by insulin, even transient usage within the past 1 year
  3. Type 1 diabetes mellitus
  4. Abnormal condition of gastrointestinal tract against the absorption of oral drugs
  5. 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
  6. 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
  7. Usage of the other hormone medicines such as cortical hormone, immunosuppressive agents or cytotoxic drugs within the past 2 months
  8. psychotic
  9. Allergic history to sulfonylurea drugs
  10. Diabetic coma or diabetic ketoacidosis
  11. In use of the miconazole
  12. Pregnancy or breeding women
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736515


Locations
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China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Beijing Hospital
Beijing, Beijing, China, 100730
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
China, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150086
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030
China, Shanghai
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200233
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China, Zhejiang
SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Sponsors and Collaborators
Servier (Tianjin) Pharmaceutical Co. LTD.
Investigators
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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
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Servier (Tianjin) Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT00736515    
Other Study ID Numbers: IC4-5702-205-CHN
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Servier (Tianjin) Pharmaceutical Co. LTD.:
combination therapy,monotherapy,gliclazide MR,insulin,CGMS
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
 Insulin, Globin Zinc
Insulin Glargine
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs