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

March 29, 2018 updated by: Merck Sharp & Dohme LLC

A Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sitagliptin/Sitagliptin/Placebo
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Drug: sitagliptin
Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
Other Names:
  • MK0431
  • sitagliptin phosphate
Drug: Comparator: Placebo
Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
Experimental: Sitagliptin/Placebo/Sitaglipitin
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Drug: sitagliptin
Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
Other Names:
  • MK0431
  • sitagliptin phosphate
Drug: Comparator: Placebo
Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
Experimental: Placebo/Sitagliptin/Sitagliptin
Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
Drug: sitagliptin
Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
Other Names:
  • MK0431
  • sitagliptin phosphate
Drug: Comparator: Placebo
Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
190 minutes to 340 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose
Time Frame: 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).
190 minutes to 340 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2009

Primary Completion (Actual)

June 10, 2009

Study Completion (Actual)

July 21, 2009

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-179
  • 2009_584 (Other Identifier: Merck Registration Number)
  • CTRI/2009/091/000457 (Registry Identifier: CTRI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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