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Sponsors and Collaborators: |
Texas Diabetes Institute UTHSCSA Takeda Pharmaceuticals North America |
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Information provided by: | Texas Diabetes Institute |
ClinicalTrials.gov Identifier: | NCT00220961 |
The purpose of this study is to examine whether pioglitazone versus placebo can reduce the conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus
Condition | Intervention | Phase |
---|---|---|
Impaired Glucose Tolerance Type 2 Diabetes |
Drug: Pioglitazone |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Actos Now for Prevention of Diabetes (ACT NOW) |
Estimated Enrollment: | 600 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | May 2007 |
IGT is a prediabetic state. If IGT can be prevented from progressing to overt diabetes, the hyperglycemia-related complications of this devastating disease can be prevented. Subjects with IGT will be identified with an oral glucose tolerance test (OGTT). Eligible subjects also will have a measurement of first phase insulin secretion and insulin sensitivity using the frequently sampled intravenous glucose tolerance test (FSIVGTT) and carotid intimal media thickness using carotid ultrasound. Following these measurements subjects will be randomized to receive pioglitazone or placebo and they will return every 3 months for determination of fasting plasma glucose (FPG) concentration and interim medical history. Recruitment will take place over 15 months. From the time that the recruitment period ends, subjects will be followed for a total of 24 months on pioglitazone or placebo. The OGTT will be repeated at 15,27, and 39 months, or if the FPG is ≥ 126 mg/dl on the 3-month follow up visits. If the diagnosis of diabetes is established before month 39 or at month 39, the FSIVGTT and carotid ultrasound will be repeated. At 39 months, subjects will be washed out of pioglitazone or placebo and the OGTT, FSIVGTT, and carotid ultrasound will be repeated at month 45.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following:
Exclusion Criteria:
United States, Arizona | |
Carl T. Hayden VA Medical Center | |
Phoenix, Arizona, United States, 85012 | |
United States, California | |
USC-Keck School of Medicine | |
Los Angeles, California, United States, 90033 | |
University of California San Diego-San Diego VA Medical Center | |
San Diego, California, United States, 92161 | |
United States, District of Columbia | |
Georgetown University | |
Washington, District of Columbia, United States, 20007 | |
United States, Louisiana | |
Pennington Biomedical Research Center | |
Baton Rouge, Louisiana, United States, 70808 | |
United States, New York | |
SUNY Health Science Center | |
Brooklyn, New York, United States, 11203 | |
United States, Tennessee | |
University of Tennessee | |
Memphis, Tennessee, United States, 38163 | |
United States, Texas | |
Texas Diabetes Institute | |
San Antonio, Texas, United States, 78207 |
Principal Investigator: | Ralph A. DeFronzo, M.D. | Texas Diabetes Institute |
Study ID Numbers: | 02-062A |
Study First Received: | September 14, 2005 |
Last Updated: | February 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00220961 History of Changes |
Health Authority: | United States: Institutional Review Board |
Impaired Glucose Tolerance Type 2 Diabetes Prevention Pioglitazone |
Hypoglycemic Agents Hyperglycemia Metabolic Diseases Pioglitazone Glucose Intolerance Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Hyperglycemia Metabolic Diseases Pioglitazone Physiological Effects of Drugs Glucose Intolerance |
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |