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

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ClinicalTrials.gov Identifier: NCT01006018
Recruitment Status : Terminated (Unanticipated delays due to sterilization/stabilization testing of GLP-1.)
First Posted : November 2, 2009
Results First Posted : June 7, 2013
Last Update Posted : December 5, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. Mary Rhee, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Prediabetic State
Interventions Drug: Sitagliptin + Pioglitazone PLACEBO
Drug: Sitagliptin + Pioglitazone
Drug: PLACEBO
Enrollment 3
Recruitment Details

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  
Arm/Group Title Sitagliptin + Pioglitazone PLACEBO Sitagliptin + Pioglitazone PLACEBO
Hide Arm/Group Description

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

+ pioglitazone PLACEBO daily by mouth

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

+ pioglitazone (TZD) 15 mg daily by mouth

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

+ pioglitazone (TZD) PLACEBO daily by mouth

Period Title: Overall Study
Started 0 0 0
Completed 0 0 0
Not Completed 0 0 0
Arm/Group Title Sitagliptin + Pioglitazone PLACEBO Sitagliptin + Pioglitazone PLACEBO Total
Hide Arm/Group Description

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

+ pioglitazone PLACEBO daily by mouth

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

+ pioglitazone (TZD) 15 mg daily by mouth

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

+ pioglitazone (TZD) PLACEBO daily by mouth

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 0
Hide Baseline Analysis Population Description
[Not Specified]
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
Female
Male
1.Primary Outcome
Title Insulin Secretion
Hide Description Not measured as study was prematurely terminated due to unanticipated delays.
Time Frame baseline, 6 months, 9 months (after a 3 month washout)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sitagliptin + Pioglitazone PLACEBO Sitagliptin + Pioglitazone PLACEBO
Hide Arm/Group Description:

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

+ pioglitazone PLACEBO daily by mouth

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

+ pioglitazone (TZD) 15 mg daily by mouth

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

+ pioglitazone (TZD) PLACEBO daily by mouth

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin + Pioglitazone PLACEBO Sitagliptin + Pioglitazone PLACEBO
Hide Arm/Group Description

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

+ pioglitazone PLACEBO daily by mouth

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

+ pioglitazone (TZD) 15 mg daily by mouth

Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth

+ pioglitazone (TZD) PLACEBO daily by mouth

All-Cause Mortality
Sitagliptin + Pioglitazone PLACEBO Sitagliptin + Pioglitazone PLACEBO
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin + Pioglitazone PLACEBO Sitagliptin + Pioglitazone PLACEBO
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sitagliptin + Pioglitazone PLACEBO Sitagliptin + Pioglitazone PLACEBO
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
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
Responsible Party: Dr. Mary Rhee, Emory University
ClinicalTrials.gov Identifier: NCT01006018     History of Changes
Other Study ID Numbers: IRB00015390
First Submitted: October 27, 2009
First Posted: November 2, 2009
Results First Submitted: March 14, 2013
Results First Posted: June 7, 2013
Last Update Posted: December 5, 2013