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

Servier

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Gliclazide MR and Insulin Glargine Injection; Drug: Biosynthetic Human Insulin Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736515

IC4-5702-205-CHN

Details and patient eligibility

About

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.

Full 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

Enrollment: 160 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Combination therapy

Experimental group

Description:

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

Treatment:

Drug: Gliclazide MR and Insulin Glargine Injection

monotherapy

Active Comparator group

Description:

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.

Treatment:

Drug: Biosynthetic Human Insulin Injection