Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sitagliptin metformin · 4 trials · 2 indications
A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sitagliptin phosphate (+) metformin hydrochloride |
| 2 | ACTIVE_COMPARATOR | pioglitazone |
| Treatment A | ACTIVE_COMPARATOR | 50 mg sitagliptin and 500 mg metformin as individual tablets |
| Treatment B | EXPERIMENTAL | sitagliptin/metformin 50 mg/500 mg tablet |
| Treatment C | ACTIVE_COMPARATOR | 50 mg sitagliptin and 1000 mg metformin as individual tablets |
| Treatment D | EXPERIMENTAL | sitagliptin/metformin 50 mg/1000 mg tablet |
| Treatment E | ACTIVE_COMPARATOR | 50 mg sitagliptin and 850 mg metformin as individual tablets |
| Treatment F | EXPERIMENTAL | sitagliptin/metformin 50 mg/850 mg tablet |
| Name | Type | Description |
|---|---|---|
| sitagliptin phosphate (+) metformin hydrochloride | DRUG | sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an \~32 wk treatment period |
| Comparator: pioglitazone | DRUG | pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an \~32-wk treatment period. |
| metformin | DRUG | metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period |
| Comparator: metformin 500mg | DRUG | A single dose of metformin 500 mg tablet |
| Comparator: sitagliptin | DRUG | A single dose of 50 mg sitagliptin tablet |
| Comparator: FMI sitagliptin / metformin 50 mg/500 mg FDC tablet | DRUG | A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet |
| Comparator: FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet | DRUG | A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet |
| Comparator: FMI sitagliptin/metformin 50 mg/850 mg FDC tablet | DRUG | A single dose of FMI sitagliptin/metformin 50 mg/850 mg FDC tablet |
| Comparator: metformin 1000 mg | DRUG | A single dose of metformin 1000 mg tablet |
| Comparator: metformin 850 mg | DRUG | A single dose of metformin 850 mg tablet |
| Comparator: metformin 500 mg | DRUG | A single dose of metformin 500 mg tablets |
| Comparator: FMI sitagliptin/metformin 50 mg/500 mg FDC tablet | DRUG | A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet |
General Inclusion Criteria: * Patient has type 2 diabetes mellitus * Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy General Exclusion Criteria: * Patient has a history of type 1 diabetes mellitus or history of ketoacidosis * Patient was on a...
Sitagliptin metformin is a combination therapy for type 2 diabetes and type 2 diabetes mellitus. It combines sitagliptin, a DPP4 inhibitor, with metformin. The combination is designed to improve blood sugar control in adults with type 2 diabetes. It is developed by Merck & Company, Inc.
Sitagliptin metformin targets DPP4 (dipeptidyl peptidase-4). Sitagliptin is a DPP4 inhibitor, which works by blocking the DPP4 enzyme to increase incretin levels and help regulate blood glucose. Metformin is a biguanide that reduces hepatic glucose production and improves insulin sensitivity.
Sitagliptin metformin is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the company responsible for the development and manufacturing of this combination therapy.
Sitagliptin metformin is in Phase 1 clinical development. The available trials include Phase 1 studies focused on bioequivalence, as well as completed Phase 3 studies in patients with type 2 diabetes mellitus. It is an investigational combination and has not been approved by the FDA.
Sitagliptin metformin has been studied in several clinical trials, including NCT00961857 and NCT00961480, which are Phase 1 bioequivalence studies. Phase 3 trials include NCT00532935 and NCT00482729, which evaluated the combination in patients with type 2 diabetes mellitus. All listed trials are completed.