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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Overweight; Healthy; Obesity

Treatments: Drug: Placebo; Drug: Comparator: Pioglitazone; Drug: Comparator: Hyperinsulinemic Euglycemic Clamp

Study type: Interventional

Funder types: Industry

Identifiers

NCT01115712

0000-170

170 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

Pioglitazone 30 mg

Active Comparator group

Description:

Pioglitazone 30 mg

Treatment:

Drug: Comparator: Hyperinsulinemic Euglycemic Clamp

Drug: Comparator: Pioglitazone

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Comparator: Hyperinsulinemic Euglycemic Clamp