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Clinical Trial Details

Trial ID: L6917
Source ID: NCT00220961
Associated Drug: Pioglitazone
Title: Actos Now for Prevention of Diabetes (ACT NOW)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00220961/results
Conditions: Impaired Glucose Tolerance|Type 2 Diabetes
Interventions: DRUG: Pioglitazone|DRUG: Placebo
Outcome Measures: Primary: Prevention of Type 2 Diabetes, Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization, 2.4 years | Secondary: Change From Baseline in Fasting Plasma Glucose of 2.4 Years, Fasting Plasma Glucose, Baseline versus 2.4 years|Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test, Insulin secretion, Baseline versus 2.4 years|Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values), Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity., Baseline versus 2.4 years|Change in Atherosclerosis, carotid intima thickness, Baseline versus 2.4 years
Sponsor/Collaborators: Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: University of Texas|Takeda Pharmaceuticals North America, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 602
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2004-01
Completion Date: 2010-04
Results First Posted: 2016-08-11
Last Update Posted: 2016-08-11
Locations: Carl T. Hayden VA Medical Center, Phoenix, Arizona, 85012, United States|USC-Keck School of Medicine, Los Angeles, California, 90033, United States|University of California San Diego-San Diego VA Medical Center, San Diego, California, 92161, United States|Georgetown University, Washington, District of Columbia, 20007, United States|Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States|SUNY Health Science Center, Brooklyn, New York, 11203, United States|University of Tennessee, Memphis, Tennessee, 38163, United States|Texas Diabetes Institute, San Antonio, Texas, 78207, United States
URL: https://clinicaltrials.gov/show/NCT00220961