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
Results First Received: March 14, 2013  
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
Condition: Prediabetic State
Interventions: Drug: Sitagliptin + Pioglitazone PLACEBO
Drug: Sitagliptin + Pioglitazone
Drug: PLACEBO

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Only 3 control (normal glucose tolerance) subjects were enrolled to obtain results in normal subjects for the hyperglycemic clamp (without GLP-1 or arginine). No samples were run, and, therefore, there are no data for the control subjects.

No subjects with impaired glucose tolerance (IGT) were recruited or enrolled in the study.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
n/a

Reporting Groups
  Description
Sitagliptin + Pioglitazone PLACEBO

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

+ pioglitazone PLACEBO daily by mouth

Sitagliptin + Pioglitazone

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

+ pioglitazone (TZD) 15 mg daily by mouth

PLACEBO

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

+ pioglitazone (TZD) PLACEBO daily by mouth


Participant Flow:   Overall Study
    Sitagliptin + Pioglitazone PLACEBO     Sitagliptin + Pioglitazone     PLACEBO  
STARTED     0     0     0  
COMPLETED     0     0     0  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
n/a

Reporting Groups
  Description
Sitagliptin + Pioglitazone PLACEBO

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

+ pioglitazone PLACEBO daily by mouth

Sitagliptin + Pioglitazone

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

+ pioglitazone (TZD) 15 mg daily by mouth

PLACEBO

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

+ pioglitazone (TZD) PLACEBO daily by mouth

Total Total of all reporting groups

Baseline Measures
    Sitagliptin + Pioglitazone PLACEBO     Sitagliptin + Pioglitazone     PLACEBO     Total  
Number of Participants  
[units: participants]
  0     0     0     0  
Age  
[units: participants]
Mean ± Standard Deviation
               
Gender  
[units: participants]
       
Female                  
Male                  



  Outcome Measures

1.  Primary:   Insulin Secretion   [ Time Frame: baseline, 6 months, 9 months (after a 3 month washout) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mary Rhee, M.D.
Organization: Emory University
phone: 404-778-1666
e-mail: mrhee@emory.edu


No publications provided


Responsible Party: Dr. Mary Rhee, 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