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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00888238
First received: April 24, 2009
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  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
Drug: Comparator: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Insulin Secretion Rate (ISR) During 190 - 340 Minutes Post-dose [ Time Frame: 190 minutes to 340 minutes ] [ Designated as safety issue: No ]
    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:
  • Glucose Infusion Rate (GIR) During 190 - 340 Minutes Post-dose [ Time Frame: 190 minutes to 340 minutes ] [ Designated as safety issue: No ]
    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).


Enrollment: 12
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • sitagliptin phosphate
  • MK0431
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:
  • sitagliptin phosphate
  • MK0431
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:
  • sitagliptin phosphate
  • MK0431
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
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00888238     History of Changes
Other Study ID Numbers: 2009_584, MK0431-179
Study First Received: April 24, 2009
Results First Received: May 24, 2010
Last Updated: July 6, 2010
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013