Phase 3
N=602
Actos Now for Prevention of Diabetes (ACT NOW)
Impaired Glucose Tolerance · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00220961 ↗Enrolled (actual)
602
Serious AEs
0.7%
Results posted
Aug 2016
Primary outcome: Primary: Prevention of Type 2 Diabetes — 16.1; 5.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pioglitazone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevention of Type 2 Diabetes |
16.1; 5.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose of 2.4 Years |
-4.0; -10.7 | — |
| SECONDARY Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test |
35; 25 | — |
| SECONDARY Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values) |
0.7; 3.6 | — |
| SECONDARY Change in Atherosclerosis |
1.7; 3.2 | — |
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
Eligibility Criteria
Inclusion Criteria
- Men and women
- All ethnic groups
- 18 years of age and older
- Impaired glucose tolerance by glucose tolerance test (fasting glucose 95-125 mg/dl and 2 hr glucose of 140-199 mg/dl)
- At least one of the following:
- One or more components of the insulin resistance syndrome (HDL 150 mg/dl, blood pressure > 135/85 mmHg, BMI > 24 kg/m2, waist circumference > 102 cm in men and > 88 cm in women)
- One or more first degree relatives with type 2 diabetes
- History of gestational diabetes
- Polycystic ovarian disease
- Minority ethnic background (Mexican American, African American, Asian and Pacific Islanders, Native American)
Exclusion Criteria
- Type 2 diabetes
- Previously treated with thiazolidinediones (ever) or metformin (within one year)
- Previously treated with a sulfonylurea, a meglitinide, an alpha glucosidase inhibitor for more than a week within last year or within the 3 months prior to randomization
- Previously treated with insulin (other than during pregnancy) for more than one week within the last year or within the 3 months prior to randomization
- Cardiovascular disease
- Hospitalization for treatment of heart disease or stroke in past 6 months
- New York Heart Association Functional Class > 2
- Left bundle branch block or third degree AV block
- Aortic stenosis
- SBP > 180 mmHg or DBP > 105 mmHg
- Renal disease
- Anemia
- Hepatitis
- GI diseases (pancreatitis, inflammatory bowel disease)
- Recent or significant abdominal surgery
- Advanced pulmonary disease
- Chronic infections
- Weight loss > 10% in past 6 months
- Pregnancy and childbearing
- Major psychiatric disorders
- Excessive alcohol intake
- Thiazide use > 25 mg per day
- Non-selective beta blockers
- Niacin
- Systemic glucocorticoids
- Weight loss or weight gain medication
- Thyroid disease-suboptimally treated
- Active endocrine diseases (Cushing's, acromegaly)
- Plasma triglycerides over 400 mg/dl (despite treatment)
- History bladder cancer
- Hematuria
Data sourced from ClinicalTrials.gov (NCT00220961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.