A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males (MK-0431-179)

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: sitagliptin

• Registration Number: NCT00888238
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Study Start: 2009-05-12
• Primary Completion: 2009-06-10
• Study Completion: 2009-07-21
• Results First Submitted: 2010-05-24
• Results First Submitted QC: 2010-07-06
• Results First Posted: 2010-08-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sitagliptin/Sitagliptin/Placebo	sitagliptin	Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Sitagliptin/Placebo/Sitaglipitin	sitagliptin	Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Placebo/Sitagliptin/Sitagliptin	sitagliptin	Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).