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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00888238
First received: April 24, 2009
Last updated: May 9, 2014
Last verified: May 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00888238     History of Changes
Other Study ID Numbers: 0431-179, 2009_584, CTRI/2009/091/000457
Study First Received: April 24, 2009
Results First Received: May 24, 2010
Last Updated: May 9, 2014
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014