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
Sponsor:
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
  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:

  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
  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 of Tongji Medical College of Huazhong University of Science & 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, Globin Zinc
Insulin
Insulin, Long-Acting
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014