Compare the Effect of DPP-IV Inhibitor or TZD on Glycemic Variability and Oxidative Stress in Patient With 2 Diabetes

May 5, 2011 updated by: Korea University Anam Hospital

An Open-label, Randomized, Active-controlled Study to Compare the Effect of DPP-IV Inhibitor and TZD as add-on Therapy to Metformin on Glycemic Variability and Oxidative Stress in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

The purpose of this study is to compare the effect of vildagliptin vs. pioglitazone to oxidative stress on daily blood glucose fluctuations, in patients with type 2 diabetes that was inadequately controlled by metformin.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Activation of oxidative stress by glucose fluctuations plays a major role in the pathogenesis of diabetic complication. Dipeptidyl peptidase IV (DPP-IV), such as vildagliptin, enhances glucose-induced insulin secretion, decreases glucagon secretion, and reduces postprandial hyperglycemia and may also improve acute fluctuations of glucose. We believe that vildagliptin may exert an effect of decreasing oxidative stress by reducing glucose excursion.

Study Type

Interventional

Enrollment (Anticipated)

80

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 Contact

Study Contact Backup

  • Name: Juri Park, Dr.,Ph.D
  • Phone Number: 82-2-2224-2590
  • Email: poirio@naver.com

Study Locations

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female with age 18-80 years
  • Type 2 diabetes mellitus
  • On stable dose of metformin (more than 1000mg) for at least 1 month
  • HbA1c 7~10%
  • Subjects on statins, ACE inhibitors, ARBs and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study
  • BP under control - no change required to BP medications
  • Agreement to maintain prior diet & exercise

Exclusion Criteria:

  • Type 1 DM or Any kind of secondary DM
  • Pregnant or lactating women.
  • Treatment with sulfonylurea, α-glucosidase inhibitor, glinide, GLP-1 analogues, DPP-IV inhibitors or insulin therapy within 1 month prior to informed consent.
  • Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent.
  • HbA1c <7% or >10%
  • Uncontrolled hypertension ( BP > 160/100 mmHg)
  • Congestive heart failure (NYHA class I to IV).

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pioglitazone
pioglitazone: 15mg, QD, PO, 16 weeks
Drug: pioglitazone
15mg, QD, PO, 16 weeks
Experimental: vildagliptin
vildagliptin 50mg,BID,PO,16 weeks
Drug: Galvus (vildagliptin)
50mg BID, PO, for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic Variability
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Oxidative stress
Time Frame: 16 weeks
16 weeks
HbA1C
Time Frame: 16 weeks
16 weeks
hypoglycemia
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

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

Sponsor

Korea University Anam 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

April 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

May 9, 2011

Last Update Submitted That Met QC Criteria

May 5, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN10016-002

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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