Phase 1
Completed N=211
Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)
Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov NCT00511108 ↗
Enrolled (actual)
211
Serious AEs
1.0%
Results posted
Mar 2010
Primary outcomePrimary: Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment — -17.2; -4.9; -29.8; 12.5 pg*hr/mL — p=0.002
Summary
A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment |
-17.2; -4.9; -29.8; 12.5 | 0.002 sig |
| PRIMARY Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment |
71.5; 27.0; 125.2; -2.3 | <0.001 sig |
| SECONDARY Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment |
-209.8; -245.6; -389.2; 18.6 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has type 2 diabetes mellitus
- Male
- Female that is highly unlikely to become pregnant
- Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)
Exclusion Criteria
- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Patient has required insulin therapy within the past 12 weeks
- Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones [TZDs]) within the prior 12 weeks of the screening visit.
Data sourced from ClinicalTrials.gov (NCT00511108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.