Type 2 Diabetes Mellitus
Conditions
Brief summary
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.
Interventions
DRUGsitagliptin
Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
DRUGComparator: Placebo
Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is an Asian Indian male between 18 to 45 years of age * Subject is in good health * Subject is a nonsmoker or has not used nicotine-containing products for six months * Subject is willing to avoid strenuous activity
Exclusion criteria
* Subject has a history of stroke, seizures, or major neurological disorders * Subject has irritable bowel disease or recurrent nausea, vomiting, diarrhea, or abdominal pain * Subject has a history of high blood pressure requiring treatment * Subject has history of cancer * Subject has a history of diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose | 190 minutes to 340 minutes | ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose | 190 minutes to 340 minutes | 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). |
Participant flow
Recruitment details
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
Pre-assignment details
Subjects screened over a 1 week period.
Participants by arm
| Arm | Count |
|---|---|
| All Patients All Randomized patients | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Washout Period After Period 2 | Adverse Event | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 26.8 years STANDARD_DEVIATION 6.4 |
| Body Mass Index | 20.5 kg/m2 STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.
Time frame: 190 minutes to 340 minutes
Population: All subjects who completed a hyperglycemic clamp in each period were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin 100 mg | Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose | 9.73 ng/min | Standard Deviation 2.72 |
| Placebo | Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose | 8.03 ng/min | Standard Deviation 2.58 |
p-value: <0.00190% CI: [1.47, 1.93]ANOVA
Secondary
Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose
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).
Time frame: 190 minutes to 340 minutes
Population: All subjects who completed a hyperglycemic clamp in each period were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sitagliptin 100 mg | Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose | 15.0 mg / kg / min | Standard Deviation 2.6 |
| Placebo | Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose | 13.7 mg / kg / min | Standard Deviation 2.3 |
p-value: <0.00190% CI: [1.08, 1.52]ANOVA