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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: sitagliptin; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00888238

0431-179

2009_584 (Other Identifier)

CTRI/2009/091/000457 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups

Sitagliptin/Sitagliptin/Placebo

Experimental group

Description:

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Treatment:

Drug: Comparator: Placebo

Drug: sitagliptin

Sitagliptin/Placebo/Sitaglipitin

Experimental group

Description:

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Treatment:

Drug: Comparator: Placebo

Drug: sitagliptin

Placebo/Sitagliptin/Sitagliptin

Experimental group

Description:

Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods

Treatment:

Drug: Comparator: Placebo

Drug: sitagliptin