Effects of Vildagliptine and Glimepiride on Glucose Variability

November 19, 2015 updated by: Hye Seung Jung, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glimepiride
Starting with Glimepiride. After 3 month, switching to vildagliptin.
Drug: Vildagliptin
Drug: Glimepiride
Experimental: Vildagliptin
Starting with vildagliptin. After 3 month, switching to Glimepiride.
Drug: Vildagliptin
Drug: Glimepiride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic variability index
Time Frame: before and after 3 months of each drug administration
before and after 3 months of each drug administration
Cardiovascular disease risk factor
Time Frame: before and after 3 months of each drug administration
before and after 3 months of each drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
glucose profile and lipid profile
Time Frame: before and after 3 months of each drug administration
before and after 3 months of each drug administration
hypoglycemic index
Time Frame: before and after 3 months of each drug administration
before and after 3 months of each drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hye Seung Jung, MD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 15, 2013

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGMS_SU_Gliptin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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