Phase 3
Completed N=602
Actos Now for Prevention of Diabetes (ACT NOW)
Source: ClinicalTrials.gov NCT00220961 ↗Enrolled (actual)
602
Serious AEs
0.7%
Results posted
Aug 2016
Primary outcomePrimary: Prevention of Type 2 Diabetes — 16.1; 5.0 percentage of participants
◆ Published Evidence
Highly cited
102citations · ~8 / year
Pioglitazone slows progression of atherosclerosis in prediabetes independent of changes in cardiovascular risk factors.
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
Linked Publications (5)
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Pioglitazone slows progression of atherosclerosis in prediabetes independent of changes in cardiovascular risk factors.
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Diabetes Incidence and Glucose Tolerance after Termination of Pioglitazone Therapy: Results from ACT NOW.
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A novel insulin resistance index to monitor changes in insulin sensitivity and glucose tolerance: the ACT NOW study.
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Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus.
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Baseline adiponectin levels do not influence the response to pioglitazone in ACT NOW.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.