An interventional study of Sitagliptin + Pioglitazone PLACEBO and Sitagliptin + Pioglitazone in Prediabetic State, sponsored by Emory University. Terminated at 2 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-05.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 3 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth
Drug: Sitagliptin + Pioglitazone PLACEBO
Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth
Drug: Sitagliptin + Pioglitazone
Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth
Drug: PLACEBO
Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
Also known as: Januvia (sitagliptin), Pioglitazone (Actos)
Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
Also known as: Januvia (sitaglitin), Pioglitazone (Actos)
Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily
Also known as: Januvia (sitagliptin) PLACEBO, Pioglitazone (Actos) PLACEBO
Insulin Secretion
Not measured as study was prematurely terminated due to unanticipated delays.
Time frame: baseline, 6 months, 9 months (after a 3 month washout)
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.
| Milestone | Sitagliptin + Pioglitazone PLACEBO | Sitagliptin + Pioglitazone | PLACEBO |
|---|---|---|---|
| Started | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
Not measured as study was prematurely terminated due to unanticipated delays.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitagliptin + Pioglitazone PLACEBO | — | — | — |
| Sitagliptin + Pioglitazone | — | — | — |
| PLACEBO | — | — | — |
| Age Continuous(participants) | Sitagliptin + Pioglitazone PLACEBO | Sitagliptin + Pioglitazone | PLACEBO | Total |
|---|
| Sex: Female, Male(Participants) | Sitagliptin + Pioglitazone PLACEBO | Sitagliptin + Pioglitazone | PLACEBO | Total |
|---|
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Emory University