Actos Now for Prevention of Diabetes (ACT NOW)

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Takeda Pharmaceuticals North America, Inc.; University of Texas
• Treatments: Pioglitazone

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 < 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)

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