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

Type 2 Diabetes Clinical Trial

— CODMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736515
• Other study ID #: IC4-5702-205-CHN
• Status: Completed
• Phase: Phase 4
• Start date: October 2008
• Est. completion date: August 2011

Study information

• Verified date: March 2020
• Source: Servier (Tianjin) Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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
• 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

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Guangdong General Hospital	Guangzhou	Guangdong
China	SIR RUN RUN SHAW Hospital Affiliated to Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Servier (Tianjin) Pharmaceutical Co. LTD.

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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 anti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG		3 months
Secondary	MBG, SDBG, MAGE and MODD in the 48th CGMS		3 months
Secondary	Incidence of hypoglycemia and severe hypoglycemia		3 months
Secondary	Weight change		3 months