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 used for the treatment of Type 2 Diabetes Mellitus and Type 2 Diabetes. It is a small molecule combination therapy being developed by Merck & Company, Inc. (MRK) for metabolic conditions.
Sitagliptin metformin is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company has conducted clinical trials evaluating this combination therapy in patients with Type 2 Diabetes.
Sitagliptin metformin is in Phase 1 clinical development. While some completed trials were Phase 3 studies, the current development stage is Phase 1, and the drug remains investigational and is not approved for commercial use.
Sitagliptin metformin has been studied in four completed clinical trials. These include NCT00482729 and NCT00532935, which were Phase 3 studies in Type 2 Diabetes Mellitus, and NCT00961480 and NCT00961857, which were Phase 1 bioequivalence studies in Type 2 Diabetes.
Sitagliptin metformin is a combination of sitagliptin and metformin, and it is marketed under the brand name Janumet. The clinical trials listed under sitagliptin metformin evaluate this fixed-dose combination tablet.