Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00511108 | Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061) | PHASE1 | COMPLETED | 211 | — | — | Jul 11, 2007 | Feb 24, 2009 | May 12, 2017 | - | — |
| NCT00704132 | Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059) | PHASE1 | COMPLETED | 57 | — | — | Feb 14, 2007 | Apr 28, 2010 | May 12, 2017 | - | — |
Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC.
Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100.
Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Arm 1: drug |
| 2 | ACTIVE_COMPARATOR | Arm 2: active comparator |
| 3 | EXPERIMENTAL | Arm 3: drug + active comparator |
| 4 | PLACEBO_COMPARATOR | Arm 4: placebo comparator |
| sitagliptin | EXPERIMENTAL | Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants randomized to this arm will be administered matching placebo, daily for six weeks. |
| Name | Type | Description |
|---|---|---|
| Comparator: sitagliptin phosphate | DRUG | sitagliptin phosphate 100 mg as oral tablets. Each patient will be administered 1 tablet once daily. |
| Comparator: pioglitazone | DRUG | pioglitazone 30 mg will be supplied as oral tablets. Each patient will be administered 1 tablet once daily. |
| Comparator: placebo to pioglitazone | DRUG | pioglitazone 30 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily. |
| Comparator: placebo to sitagliptin | DRUG | sitagliptin phosphate 100 mg placebos will be supplied as oral tablets. Each patient will be administered 1 tablet once daily. |
| Comparator: placebo (unspecified) | DRUG | Matching placebo tablet, administered once daily before the morning meal. |
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: * Pati...