Type 2 Diabetes
Conditions
Keywords
combination therapy,monotherapy,gliclazide MR,insulin,CGMS
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.
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
Interventions
DRUGGliclazide 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
DRUGBiosynthetic 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
Sponsors
Servier (Tianjin) Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decreasing value of FPG and HbA1c, dosage of insulin and control rate of FPG | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| MBG, SDBG, MAGE and MODD in the 48th CGMS | 3 months |
| Incidence of hypoglycemia and severe hypoglycemia | 3 months |
| Weight change | 3 months |
Countries
China
Outcome results
None listed