Trial Outcomes & Findings for DPP-4 Inhibition and TZD for DM Prevention (NCT NCT01006018)
NCT ID: NCT01006018
Last Updated: 2013-12-05
Results Overview
Not measured as study was prematurely terminated due to unanticipated delays.
TERMINATED
NA
3 participants
baseline, 6 months, 9 months (after a 3 month washout)
2013-12-05
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DPP-4 Inhibition and TZD for DM Prevention
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: baseline, 6 months, 9 months (after a 3 month washout)Not measured as study was prematurely terminated due to unanticipated delays.
Outcome measures
Outcome data not reported
Adverse Events
Sitagliptin + Pioglitazone PLACEBO
Sitagliptin + Pioglitazone
PLACEBO
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place