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

This study has been terminated.
(Unanticipated delays due to sterilization/stabilization testing of GLP-1.)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. Mary Rhee, Emory University
ClinicalTrials.gov Identifier:
NCT01006018
First received: October 27, 2009
Last updated: November 12, 2013
Last verified: November 2013
  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: 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:


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 ]
    Not measured as study was prematurely terminated due to unanticipated delays.


Enrollment: 3
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Januvia (sitaglitin)
  • Pioglitazone (Actos)
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Mary Rhee, MD Emory University
  More Information

No publications provided

Responsible Party: Dr. Mary Rhee, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01006018     History of Changes
Other Study ID Numbers: IRB00015390
Study First Received: October 27, 2009
Results First Received: March 14, 2013
Last Updated: November 12, 2013
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014