drugset / Trial / NCT00736515

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

NCT00736515

Phase 4 Completed 160 enrolled Servier (Tianjin) Pharmaceutical Co. LTD.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-10
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Biosynthetic Human Insulin Unknown 0.4 iu/kg Subcutaneous
Comparator Biosynthetic Human Insulin Unknown 0.6 iu/kg Subcutaneous
Subject Gliclazide Small molecule 60 mg Oral
Subject Gliclazide Small molecule 120 mg Oral
Subject insulin glargine Protein / enzyme biologic 0.2 iu/kg Subcutaneous