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Completed

NCT Number: NCT00888238

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin

Drug

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

Comparator: placebo

Drug

Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2009
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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