CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 602 enrolled
Drug / intervention
Pioglitazone +1 moredrug
Likely dose
Pioglitazone 45 mg orally once dailyAI-extracted
Key inclusion· 3
  • ✓Impaired glucose tolerance: fasting glucose 95–125 mg/dL AND 2-hour glucose 140–199 mg/dL
  • ✓At least one component of insulin resistance syndrome (low HDL, elevated triglycerides, hypertension, elevated BMI, central obesity) OR one or more first-degree relatives with type 2 diabetes OR history of gestational diabetes OR polycystic ovarian disease OR minority ethnic background
  • ✓Age ≥18 years
Key exclusion· 11
  • ✕Type 2 diabetes diagnosis
  • ✕Prior thiazolidinedione use (any time) or metformin within 1 year
  • ✕Sulfonylurea, meglitinide, or alpha-glucosidase inhibitor for >1 week within past year or within 3 months prior to randomization
  • ✕Insulin therapy (except during pregnancy) for >1 week within past year or within 3 months prior to randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00220961
NCT00220961Phase 3Completed
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Actos Now for Prevention of Diabetes (ACT NOW)

The University of Texas Health Science Center at San Antonio·interventional·Posted Sep 22, 2005·Updated Aug 11, 2016

In Brief

A Phase 3 clinical trial evaluating Pioglitazone and Placebo for Impaired Glucose Tolerance and Type 2 Diabetes. Completed, enrolled 602 participants across 8 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImpaired Glucose Tolerance, Type 2 Diabetes
CountriesUnited States
CollaboratorsUniversity of Texas, Takeda Pharmaceuticals North America, Inc.

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJan 1, 2004
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago

Interventions

Pioglitazonedrug

Pioglitazone tablets - 45 mg/day

Placebodrug

Placebo tablets similar to pioglitazone tablets - 1 tablet/day