Actos Now for Prevention of Diabetes (ACT NOW)

Completed · Phase 3 · Has a placebo group

Conditions studied: Impaired Glucose Tolerance, Type 2 Diabetes

In brief

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

Key facts

Study ID

NCT00220961

Run by

The University of Texas Health Science Center at San Antonio

People needed

602

Starts

2004-01-01

Expected to finish

2010-04-01

Last updated by the study team

2016-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 40 mg/dl in females and <35 mg/dl in males, fasting triglycerides > 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)

You may not qualify if…

• 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

Where it is running

• Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States
• USC-Keck School of Medicine — Los Angeles, California, United States
• University of California San Diego-San Diego VA Medical Center — San Diego, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• SUNY Health Science Center — Brooklyn, New York, United States
• University of Tennessee — Memphis, Tennessee, United States
• Texas Diabetes Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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