NCT00736515

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Servier (Tianjin) Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-08-18
• Last updated: 2020-04-03

Locations

8 sites across 1 country: China