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

NCT01115712 | Completed Phase 1

• 2 other identifiers: 0000-170170
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy; Overweight; Obesity

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Pioglitazone 30 mg

ACTIVE COMPARATOR

Pioglitazone 30 mg

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo; Drug: Comparator: Hyperinsulinemic Euglycemic Clamp

Interventions

Placebo DRUG

Placebo (to match pioglitazone 30 mg) once daily

Placebo

Comparator: Pioglitazone DRUG

Pioglitazone 30 mg once daily

Pioglitazone 30 mg

Comparator: Hyperinsulinemic Euglycemic Clamp DRUG

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.

Pioglitazone 30 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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.

  PMID: 26543510 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 2, 2015

Record last verified: 2015-10