Trial Outcomes & Findings for A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179) (NCT NCT00888238)
NCT ID: NCT00888238
Last Updated: 2018-06-26
Results Overview
ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
190 minutes to 340 minutes
Results posted on
2018-06-26
Participant Flow
Subjects were recruited at Veeda Clinical Research Pvt. Ltd. in May 2009. First Patient Screened: 20-May-2009. Last Patient, Last Visit: 21-Jul-2009. 1 site
Subjects screened over a 1 week period.
Participant milestones
| Measure |
Sitagliptin / Sitagliptin / Placebo
Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo
|
Sitagliptin / Placebo / Sitagliptin
Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
|
Placebo / Sitagliptin / Sitagliptin
Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
|
|---|---|---|---|
|
First Period of Treatment Intervention
STARTED
|
4
|
4
|
4
|
|
First Period of Treatment Intervention
COMPLETED
|
4
|
4
|
4
|
|
First Period of Treatment Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period After Period 1
STARTED
|
4
|
4
|
4
|
|
Washout Period After Period 1
COMPLETED
|
4
|
4
|
4
|
|
Washout Period After Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Period of Treatment Intervention
STARTED
|
4
|
4
|
4
|
|
Second Period of Treatment Intervention
COMPLETED
|
4
|
4
|
4
|
|
Second Period of Treatment Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period After Period 2
STARTED
|
4
|
4
|
4
|
|
Washout Period After Period 2
COMPLETED
|
4
|
4
|
3
|
|
Washout Period After Period 2
NOT COMPLETED
|
0
|
0
|
1
|
|
Third Period of Treatment Intervention
STARTED
|
4
|
4
|
3
|
|
Third Period of Treatment Intervention
COMPLETED
|
4
|
4
|
3
|
|
Third Period of Treatment Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sitagliptin / Sitagliptin / Placebo
Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo
|
Sitagliptin / Placebo / Sitagliptin
Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
|
Placebo / Sitagliptin / Sitagliptin
Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
|
|---|---|---|---|
|
Washout Period After Period 2
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
Baseline characteristics by cohort
| Measure |
All Patients
n=12 Participants
All Randomized patients
|
|---|---|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Body Mass Index
|
20.5 kg/m2
STANDARD_DEVIATION 1.3 • n=93 Participants
|
PRIMARY outcome
Timeframe: 190 minutes to 340 minutesPopulation: All subjects who completed a hyperglycemic clamp in each period were included in the analysis.
ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.
Outcome measures
| Measure |
Sitagliptin 100 mg
n=12 Participants
11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
|
Placebo
n=12 Participants
12 subjects received a single-dose of placebo in 1 period.
|
|---|---|---|
|
Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
|
9.73 ng/min
Standard Deviation 2.72
|
8.03 ng/min
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: 190 minutes to 340 minutesPopulation: All subjects who completed a hyperglycemic clamp in each period were included in the analysis.
Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg).
Outcome measures
| Measure |
Sitagliptin 100 mg
n=12 Participants
11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
|
Placebo
n=12 Participants
12 subjects received a single-dose of placebo in 1 period.
|
|---|---|---|
|
Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose
|
15.0 mg / kg / min
Standard Deviation 2.6
|
13.7 mg / kg / min
Standard Deviation 2.3
|
Adverse Events
Sitagliptin 100 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sitagliptin 100 mg
n=12 participants at risk
11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
|
Placebo
n=12 participants at risk
12 subjects received a single-dose of placebo in 1 period.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Blister
|
8.3%
1/12 • Adverse experiences were collected from the time the consent was signed through the 14 day follow up period, after all treatment periods were completed.
Subjects were queried at each visit for any adverse experiences since the previous visit.
|
0.00%
0/12 • Adverse experiences were collected from the time the consent was signed through the 14 day follow up period, after all treatment periods were completed.
Subjects were queried at each visit for any adverse experiences since the previous visit.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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