A Method to Evaluate Glucose-Dependent Insulin Secretion in Healthy Males - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00888238

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: sitagliptin phosphate Drug: Comparator: Placebo	Phase I

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males

Further study details as provided by Merck:

Primary Outcome Measures:

Insulin secretion rate (ISR) [ Time Frame: 190 minutes to 340 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glucose infusion rate (GIR) [ Time Frame: 190 minutes to 340 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	May 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods	Drug: sitagliptin phosphate Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test. Drug: Comparator: Placebo Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888238

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_584, MK0431-179
Study First Received:	April 24, 2009
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00888238 History of Changes
Health Authority:	India: Ministry of Health

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Healthy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin
Protease Inhibitors
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Glucose Metabolism Disorders
Pharmacologic Actions
Protease Inhibitors
Sitagliptin

ClinicalTrials.gov processed this record on May 07, 2009