Effects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01115712
First received: April 30, 2010
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate whether 30 mg of pioglitazone administered once daily for up to 28 days to healthy overweight and obese subjects will lead to a significant change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp


Condition Intervention Phase
Healthy
Overweight
Obesity
Drug: Placebo
Drug: Comparator: Pioglitazone
Drug: Comparator: Hyperinsulinemic Euglycemic Clamp
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial to Measure the Effect of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing. [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
  • Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing. [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]
  • Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing [ Time Frame: Baseline and 14 days ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone 30 mg
Pioglitazone 30 mg
Drug: Comparator: Pioglitazone
Pioglitazone 30 mg once daily
Drug: Comparator: Hyperinsulinemic Euglycemic Clamp
Infusion of Glucose (20% dextrose) to achieve a glucose concentration of 90mg/dL; Infusion of Insulin at a rate of 10 mU/m2/minute from 0 to 180 minutes and at a rate of 40 mU/m2/minute from 180 to 360 minutes; Saline infusion at 60 minutes before the insulin and glucose infusions to keep the antecubital vein open.
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo (to match pioglitazone 30 mg) once daily
Drug: Comparator: Hyperinsulinemic Euglycemic Clamp
Infusion of Glucose (20% dextrose) to achieve a glucose concentration of 90mg/dL; Infusion of Insulin at a rate of 10 mU/m2/minute from 0 to 180 minutes and at a rate of 40 mU/m2/minute from 180 to 360 minutes; Saline infusion at 60 minutes before the insulin and glucose infusions to keep the antecubital vein open.

  Eligibility

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

Inclusion Criteria:

  • Subject has a BMI of greater than 28 kg/m^2 and less than or equal to 38 kg/m^2
  • Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
  • Subject is willing to avoid major dietary changes for the duration of the study

Exclusion Criteria:

  • Subject has history of diabetes (Type 1, Type 2 or steroid-induced)
  • Subject has a history of hypersensitivity to pioglitazone or other thiazolidinediones
  • Subject has a history of liver disease, other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
  • Subject has a history of congestive heart failure
  • Subject has a active or past history of atherosclerotic heart disease, heart failure, osteoporosis, osteopenia, recurrent bone fractures, or anemia
  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological or renal abnormalities or diseases
  • Subject has a history of neoplastic disease within the past 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115712

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01115712     History of Changes
Other Study ID Numbers: 2010_533, 170
Study First Received: April 30, 2010
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Merck Sharp & Dohme Corp.:
Healthy Volunteers

Additional relevant MeSH terms:
Obesity
Overweight
Insulin Resistance
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014