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

Phase 1

Completed

• Conditions: Healthy; Overweight; Obesity
• Interventions: Drug: Placebo

• Registration Number: NCT01115712
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-30
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing.	Baseline and 28 days
Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing	Baseline and 14 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing.	Baseline and 28 days
Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing	Baseline and 14 days