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

This study is currently recruiting participants.
Verified July 2011 by Emory University
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT01006018
First received: October 27, 2009
Last updated: July 26, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Prediabetic State
 Drug: Sitagliptin + Pioglitazone PLACEBO
Drug: Sitagliptin + Pioglitazone
Drug: Sitagliptin placebo + Pioglitazone placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Insulin secretion [ Time Frame: baseline, 6 months, 9 months (after a 3 month washout) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin sensitivity [ Time Frame: baseline, 6 months, 9 months (after a 3 month washout) ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin only Drug: Sitagliptin + Pioglitazone PLACEBO
Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
Other Names:
  • Januvia (sitagliptin)
  • Pioglitazone (Actos)
Experimental: Sitagliptin + Pioglitazone Drug: Sitagliptin + Pioglitazone
Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
Other Names:
  • Januvia (sitaglitin)
  • Pioglitazone (Actos)
Placebo Comparator: Placebo Drug: Sitagliptin placebo + Pioglitazone placebo
Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006018

Contacts
Contact: Grace Jama-Adan, MPH 404-778-1688 gjamaad@emory.edu

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mary Rhee            
Principal Investigator: Mary Rhee, MD            
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Mary Rhee, MD            
Principal Investigator: Mary Rhee, MD            
Sponsors and Collaborators
Emory University
  More Information

No publications provided

Responsible Party: Mary Rhee, Emory University
ClinicalTrials.gov Identifier: NCT01006018     History of Changes
Other Study ID Numbers: EU IRB15390
Study First Received: October 27, 2009
Last Updated: July 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Prediabetic State

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Sitagliptin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013