A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males
Overview
- Phase
- Phase 1
- Intervention
- sitagliptin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 12
- Primary Endpoint
- Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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
Arms & Interventions
Sitagliptin/Sitagliptin/Placebo
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Intervention: sitagliptin
Sitagliptin/Placebo/Sitaglipitin
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Intervention: sitagliptin
Placebo/Sitagliptin/Sitagliptin
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Intervention: sitagliptin
Outcomes
Primary Outcomes
Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose
Time Frame: 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 Outcomes
- Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose(190 minutes to 340 minutes)