Study of Combination Therapy of Gliclazide MR and Basal Insulin Versus Insulin Monotherapy to Treat Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

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
    

Intervention name(s): Gliclazide MR and Insulin Glargine Injection; Biosynthetic Human Insulin Injection
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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 intervention name(s): Brand Name: Diamicron MR and Lantus; Brand Name: Novolin 30R
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: combination therapy,monotherapy,gliclazide MR,insulin,CGMS