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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:
ClinicalTrials.gov Identifier:
NCT01006018
First Posted: November 2, 2009
Last Update Posted: December 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. Mary Rhee, Emory University
October 27, 2009
November 2, 2009
March 14, 2013
June 7, 2013
December 5, 2013
July 2011
December 2011   (Final data collection date for primary outcome measure)
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.
Insulin Secretion [ Time Frame: baseline, 6 months, 9 months (after a 3 month washout) ]
Complete list of historical versions of study NCT01006018 on ClinicalTrials.gov Archive Site
Not Provided
Insulin sensitivity [ Time Frame: baseline, 6 months, 9 months (after a 3 month washout) ]
Not Provided
Not Provided
 
DPP-4 Inhibition and TZD for DM Prevention
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Prediabetic State
  • Drug: Sitagliptin + Pioglitazone PLACEBO
    Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
    Other Names:
    • Januvia (sitagliptin)
    • Pioglitazone (Actos)
  • Drug: Sitagliptin + Pioglitazone
    Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
    Other Names:
    • Januvia (sitaglitin)
    • Pioglitazone (Actos)
  • Drug: PLACEBO
    Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily
    Other Names:
    • Januvia (sitagliptin) PLACEBO
    • Pioglitazone (Actos) PLACEBO
  • Experimental: Sitagliptin + Pioglitazone PLACEBO

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

    + pioglitazone PLACEBO daily by mouth

    Intervention: Drug: Sitagliptin + Pioglitazone PLACEBO
  • Experimental: Sitagliptin + Pioglitazone

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

    + pioglitazone (TZD) 15 mg daily by mouth

    Intervention: Drug: Sitagliptin + Pioglitazone
  • Placebo Comparator: PLACEBO

    Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

    + pioglitazone (TZD) PLACEBO daily by mouth

    Intervention: Drug: PLACEBO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01006018
IRB00015390
No
Not Provided
Not Provided
Dr. Mary Rhee, Emory University
Emory University
Merck Sharp & Dohme Corp.
Principal Investigator: Mary Rhee, MD Emory University
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP