Trial Outcomes & Findings for Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080) (NCT NCT00929201)
NCT ID: NCT00929201
Last Updated: 2015-08-13
Results Overview
Serum samples were used to determine the AUC from time 0 to infinity for metformin.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
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
Results posted on
2015-08-13
Participant Flow
Participant milestones
| Measure |
Sita + Met Then Sita/Met FDC
Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2.
|
Sita/Met FDC Then Sita + Met
Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
|
|---|---|---|
|
Period 1
STARTED
|
30
|
31
|
|
Period 1
COMPLETED
|
30
|
30
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
7-day Washout
STARTED
|
30
|
30
|
|
7-day Washout
COMPLETED
|
30
|
30
|
|
7-day Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
30
|
30
|
|
Period 2
COMPLETED
|
30
|
30
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sita + Met Then Sita/Met FDC
Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2.
|
Sita/Met FDC Then Sita + Met
Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)
Baseline characteristics by cohort
| Measure |
All Participants
n=61 Participants
All randomized participants
|
|---|---|
|
Age, Continuous
|
32.4 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Height
|
164.9 Centimeters
n=5 Participants
|
|
Weight
|
73.0 Kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 postdosePopulation: All participants who completed and who had pharmacokinetic data available from at least one treatment period
Serum samples were used to determine the AUC from time 0 to infinity for metformin.
Outcome measures
| Measure |
Sita + Met
n=60 Participants
Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
|
Sita/Met FDC
n=60 Participants
Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) FDC tablet administered as a single dose
|
|---|---|---|
|
Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin
|
7.65 μg * hr/mL
Standard Deviation 1.39
|
7.45 μg * hr/mL
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: 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 postdosePopulation: All participants who completed and who had pharmacokinetic data available from at least one treatment period
Serum samples were used to determine the maximum concentration for metformin.
Outcome measures
| Measure |
Sita + Met
n=60 Participants
Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
|
Sita/Met FDC
n=60 Participants
Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) FDC tablet administered as a single dose
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) of Metformin
|
929 ng/mL
Standard Deviation 181
|
887 ng/mL
Standard Deviation 187
|
Adverse Events
Sita + Met
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sita/Met FDC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sita + Met
n=60 participants at risk
Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
|
Sita/Met FDC
n=61 participants at risk
Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.3%
2/60 • Up to 24 days (including 14 days after administration of study drug in the last treatment period)
All participants as treated defined as all participants who received at least one dose of study drug
|
9.8%
6/61 • Up to 24 days (including 14 days after administration of study drug in the last treatment period)
All participants as treated defined as all participants who received at least one dose of study drug
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER