Phase 1
N=12
A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00888238 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose — 9.73; 8.03 ng/min — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- sitagliptin (Drug); Comparator: Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose |
9.73; 8.03 | <0.001 sig |
| SECONDARY Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose |
15.0; 13.7 | <0.001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00888238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.