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

Healthy Clinical Trial

Official title:

A Randomized Clinical Trial to Measure the Effect of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115712
• Other study ID #: 0000-170
• Secondary ID: 170
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2010
• Last updated: October 1, 2015
• Start date: May 2010
• Est. completion date: September 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Obesity
• Overweight

Intervention

Drug:
• Placebo
Placebo (to match pioglitazone 30 mg) once daily
• Comparator: Pioglitazone
Pioglitazone 30 mg once daily
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Shankar SS, Shankar RR, Railkar RA, Beals CR, Steinberg HO, Kelley DE. Early Clinical Detection of Pharmacologic Response in Insulin Action in a Nondiabetic Insulin-Resistant Population. Curr Ther Res Clin Exp. 2015 Aug 14;77:83-9. doi: 10.1016/j.curtheres.2015.08.001. eCollection 2015 Dec. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No