Status:
COMPLETED
Actos Now for Prevention of Diabetes (ACT NOW)
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
University of Texas
Takeda Pharmaceuticals North America, Inc.
Conditions:
Impaired Glucose Tolerance
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed Description
IGT is a prediabetic state. If IGT can be prevented from progressing to overt diabetes, the hyperglycemia-related complications of this devastating disease can be prevented. Subjects with IGT will be ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT00220961
Start Date
January 1 2004
End Date
April 1 2010
Last Update
August 11 2016
Active Locations (8)
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1
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
2
USC-Keck School of Medicine
Los Angeles, California, United States, 90033
3
University of California San Diego-San Diego VA Medical Center
San Diego, California, United States, 92161
4
Georgetown University
Washington D.C., District of Columbia, United States, 20007