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

October 27, 2009
November 12, 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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01006018
IRB00015390
No
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