Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Co-administration of sitagliptin and metformin · 1 trial · 1 indication
AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.
| Arm | Type | Description |
|---|---|---|
| 1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850 | EXPERIMENTAL | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 500 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin |
| 2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC | EXPERIMENTAL | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 850 mg metformin * Co-administration of 50 mg sitagliptin and 500mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet |
| 3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500 | EXPERIMENTAL | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/850 mg FDC tablet * sitagliptin/metformin 50 mg/500 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500mg metformin |
| 4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC | EXPERIMENTAL | Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments: * sitagliptin/metformin 50 mg/850 mg FDC tablet * Co-administration of 50 mg sitagliptin and 500 mg metformin * Co-administration of 50 mg sitagliptin and 850 mg metformin * sitagliptin/metformin 50 mg/500 mg FDC tablet |
| Name | Type | Description |
|---|---|---|
| Co-administration of 50 mg sitagliptin and 500 mg metformin | DRUG | Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours. |
| sitagliptin/metformin 50 mg/500 mg tablet | DRUG | Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours. |
| Co-administration of 50 mg sitagliptin and 850 mg metformin | DRUG | Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours. |
| sitagliptin/metformin 50 mg/850 mg tablet | DRUG | Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours. |
Inclusion Criteria: * Subject is of Chinese descent * Subject is in good health * Subject is a non-smoker Exclusion Criteria: * Subject has a history of stroke or chronic seizures * Subject has a history of cancer * Subject has had major surgery, donated blood or participated in another investiga...
Top 16 of 30 competitors
Co-administration of sitagliptin and metformin refers to giving the two small molecule drugs together as a combination treatment for type 2 diabetes. The combination is being studied by Merck & Company, Inc. under the ticker MRK. It is also known as co-administration of 50 mg sitagliptin and 500 mg metformin.
Co-administration of sitagliptin and metformin is being studied for type 2 diabetes, a metabolic condition. The combination pairs sitagliptin with metformin in a single treatment approach. Development is in Phase 1, so the combination remains investigational and is not established as an approved therapy based on the available information.
Merck & Company, Inc., which trades under the ticker MRK, is the developer of the co-administration of sitagliptin and metformin. The company is sponsoring the clinical work evaluating the combination tablet for type 2 diabetes.
Co-administration of sitagliptin and metformin is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program is investigational and remains in clinical development for type 2 diabetes.
The combination has been evaluated in one completed Phase 1 trial, NCT01093794, titled Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122). That randomized, controlled trial enrolled 28 healthy male volunteers aged 18 years and older and was conducted in type 2 diabetes. No trials are currently active.