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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00103857 | MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036) | PHASE3 | COMPLETED | 1,208 | — | — | Mar 17, 2005 | Feb 21, 2008 | May 5, 2017 | - | — |
HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MK0431 100 mg q.d. |
| 2 | ACTIVE_COMPARATOR | Metformin 500 mg b.i.d. |
| 3 | ACTIVE_COMPARATOR | Metformin 1000 mg b.i.d. |
| 4 | EXPERIMENTAL | Coadministration of MK0431 and Metformin 50/500 mg b.i.d. |
| 5 | EXPERIMENTAL | Coadministration of MK0431 and Metformin 50/1000 mg b.i.d. |
| 6 | PLACEBO_COMPARATOR | Placebo/Metformin 1000 mg b.i.d. |
| 7 | EXPERIMENTAL | Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d. |
| Name | Type | Description |
|---|---|---|
| Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily) | DRUG | MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks. |
| Comparator: MK0431 100 mg q.d. (q.d. = once daily) | DRUG | MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks. |
| Comparator: Placebo (Phase A)/Metformin (Phase B) | DRUG | During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks. |
| Comparator: Metformin 500 mg b.i.d. | DRUG | Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks. |
| Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d. | DRUG | MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks. |
| Comparator: Metformin 1000 mg b.i.d. | DRUG | Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks. |
Inclusion Criteria: 54-Week Base Study: * Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes) 50-Week Extension Study: * Patients who complete the 54-week base study are eligible to enter the 50-week extension study Exclusion Criteria: * Patients...