Skip to main content
OpenTrials
Completed

NCT Number: NCT01812122

Effects of Vildagliptine and Glimepiride on Glucose Variability

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glimepiride

Drug

Vildagliptin

Drug

Primary outcomes

  1. Glycemic variability index

    Time frame: before and after 3 months of each drug administration

  2. Cardiovascular disease risk factor

    Time frame: before and after 3 months of each drug administration

Secondary outcomes

  1. glucose profile and lipid profile

    Time frame: before and after 3 months of each drug administration

  2. hypoglycemic index

    Time frame: before and after 3 months of each drug administration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effects of Vildagliptine and Glimepiride on Glycemic Variability and Cardiovascular Parameters in Patients With Type 2 Diabetes by CGMS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2013
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.