DPP-4 Inhibition and TZD for DM Prevention (DInT DM)

November 12, 2013 updated by: Dr. Mary Rhee, Emory University

DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)

To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial 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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Impaired glucose tolerance (IGT) by oral glucose tolerance test

Exclusion Criteria:

  • History of diabetes mellitus
  • History of congestive heart failure
  • History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)
  • History of liver disease (ALT or AST >2.5 times the upper limit of normals)
  • History of renal disease (serum creatinine >1.5 mg/dl)
  • History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment)
  • Current treatment with glucocorticoids
  • History of immune disorder, including HIV
  • Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin + Pioglitazone PLACEBO

Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth

+ pioglitazone PLACEBO daily by mouth
Drug: Sitagliptin + Pioglitazone PLACEBO
Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
Other Names:
  • Januvia (sitagliptin)
  • Pioglitazone (Actos)
Experimental: Sitagliptin + Pioglitazone

Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth

+ pioglitazone (TZD) 15 mg daily by mouth
Drug: Sitagliptin + Pioglitazone
Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
Other Names:
  • Pioglitazone (Actos)
  • Januvia (sitaglitin)
Placebo Comparator: PLACEBO

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

+ pioglitazone (TZD) PLACEBO daily by mouth
Drug: PLACEBO
Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily
Other Names:
  • Januvia (sitagliptin) PLACEBO
  • Pioglitazone (Actos) PLACEBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Secretion
Time Frame: baseline, 6 months, 9 months (after a 3 month washout)
Not measured as study was prematurely terminated due to unanticipated delays.
baseline, 6 months, 9 months (after a 3 month washout)

Collaborators and Investigators

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

Sponsor

Emory University

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Mary Rhee, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00015390

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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3
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