Back to resultsEffects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170)
Primary Purpose
Healthy, Overweight, Obesity
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Comparator: Pioglitazone
Comparator: Hyperinsulinemic Euglycemic Clamp
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Healthy Volunteers
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pioglitazone 30 mg
Placebo
Arm Description
Pioglitazone 30 mg
Placebo
Outcomes
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.
Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing
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.
Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing
Full Information
NCT ID
NCT01115712
First Posted
April 30, 2010
Last Updated
October 1, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01115712
Brief Title
Effects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170)
Official Title
A Randomized Clinical Trial to Measure the Effect of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Overweight, Obesity
Keywords
Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pioglitazone 30 mg
Arm Type
Active Comparator
Arm Description
Pioglitazone 30 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (to match pioglitazone 30 mg) once daily
Intervention Type
Drug
Intervention Name(s)
Comparator: Pioglitazone
Intervention Description
Pioglitazone 30 mg once daily
Intervention Type
Drug
Intervention Name(s)
Comparator: Hyperinsulinemic Euglycemic Clamp
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26543510
Citation
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.
Results Reference
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Effects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170)
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