Effects of Vildagliptine and Glimepiride on Glucose Variability
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Interventions
- Registration Number
- NCT01812122
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The purpose of this study is to analyze the differences of blood sugar level and glycemic variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number of type 2 DM patients. The investigators also reveal influences of each drugs on cardiovascular risk factors by measuring related biomarkers.
- Detailed Description
We enroll patients with type 2 DM with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%).
Before drug administration, we conduct basal lab study including CGMS. After 3 month of random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and then conduct the same measurements. No wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- with type 2 DM
- with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open.
- who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months
- who can be applied with CGMS
- who has liver function abnormality or renal function abnormality
- who has any kind of diseases, operations, medical treatments that can affect glucose levels
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Glimepiride Vildagliptin Starting with Glimepiride. After 3 month, switching to vildagliptin. Glimepiride Glimepiride Starting with Glimepiride. After 3 month, switching to vildagliptin. Vildagliptin Vildagliptin Starting with vildagliptin. After 3 month, switching to Glimepiride. Vildagliptin Glimepiride Starting with vildagliptin. After 3 month, switching to Glimepiride.
- Primary Outcome Measures
Name Time Method Glycemic variability index before and after 3 months of each drug administration Cardiovascular disease risk factor before and after 3 months of each drug administration
- Secondary Outcome Measures
Name Time Method glucose profile and lipid profile before and after 3 months of each drug administration hypoglycemic index before and after 3 months of each drug administration
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of