Effects of Vildagliptine and Glimepiride on Glucose Variability

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: Vildagliptin; Drug: Glimepiride

Study type: Interventional

Funder types: Other

Identifiers

NCT01812122

CGMS_SU_Gliptin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• who has liver function abnormality or renal function abnormality
• who has any kind of diseases, operations, medical treatments that can affect glucose levels

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Glimepiride

Experimental group

Description:

Starting with Glimepiride. After 3 month, switching to vildagliptin.

Treatment:

Drug: Glimepiride

Drug: Vildagliptin

Vildagliptin

Experimental group

Description:

Starting with vildagliptin. After 3 month, switching to Glimepiride.

Treatment:

Drug: Glimepiride

Drug: Vildagliptin