Type 2 Diabetes Mellitus
Conditions
Brief summary
This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg fixed dose combination (FDC) tablet and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.
Interventions
DRUGSitagliptin phosphate/metformin hydrochloride FDC
Single dose sitagliptin/metformin 50/500 mg FDC tablet after consumption of a high-fat meal in one of two treatment periods.
DRUGSitagliptin phosphate
Single dose sitagliptin 50 mg tablet after consumption of a high-fat meal in one of two treatment periods.
DRUGMetformin hydrochloride
Single dose metformin 500 mg tablet after consumption of a high-fat meal in one of two treatment periods.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* is in good health * is a nonsmoker * is willing to follow all study guidelines
Exclusion criteria
* has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the participant * is a nursing mother * is unwilling to consume the required high-fat breakfast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose | Serum samples were used to determine the AUC from time 0 to infinity for metformin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of Metformin | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose | Serum samples were used to determine the maximum concentration for metformin. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All randomized participants | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 32.4 Years |
| Height | 164.9 Centimeters |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 29 Participants |
| Weight | 73.0 Kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 60 | 6 / 61 |
| serious Total, serious adverse events | 0 / 60 | 0 / 61 |
Outcome results
Primary
Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin
Serum samples were used to determine the AUC from time 0 to infinity for metformin.
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
Population: All participants who completed and who had pharmacokinetic data available from at least one treatment period
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sita + Met | Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | 7.65 μg * hr/mL | Standard Deviation 1.39 |
| Sita/Met FDC | Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin | 7.45 μg * hr/mL | Standard Deviation 1.48 |
Comparison: Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets90% CI: [0.95, 1]
Secondary
Peak Plasma Concentration (Cmax) of Metformin
Serum samples were used to determine the maximum concentration for metformin.
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose
Population: All participants who completed and who had pharmacokinetic data available from at least one treatment period
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sita + Met | Peak Plasma Concentration (Cmax) of Metformin | 929 ng/mL | Standard Deviation 181 |
| Sita/Met FDC | Peak Plasma Concentration (Cmax) of Metformin | 887 ng/mL | Standard Deviation 187 |
Comparison: Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets90% CI: [0.93, 0.98]