Actos Now for Prevention of Diabetes (ACT NOW)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Texas Diabetes Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Texas
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Texas Diabetes Institute
ClinicalTrials.gov Identifier:
NCT00220961
First received: September 14, 2005
Last updated: May 24, 2010
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Impaired Glucose Tolerance
Type 2 Diabetes
Drug: Pioglitazone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Actos Now for Prevention of Diabetes (ACT NOW)

Resource links provided by NLM:


Further study details as provided by Texas Diabetes Institute:

Primary Outcome Measures:
  • Prevention of Type 2 Diabetes

Secondary Outcome Measures:
  • Improvement in glycemic control
  • Change in insulin secretion
  • Change in insulin sensitivity
  • Improvement in cardiovascular risk factors
  • Change in blood pressure
  • Change in atherosclerosis
  • Occurrence of cardiovascular morbidity and mortality
  • Change in body composition
  • Change in adipocytokines
  • Change in plasma sex steroids
  • Change in renal function
  • Adverse events

Estimated Enrollment: 600
Study Start Date: January 2004
Estimated Study Completion Date: May 2007
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 identified with an oral glucose tolerance test (OGTT). Eligible subjects also will have a measurement of first phase insulin secretion and insulin sensitivity using the frequently sampled intravenous glucose tolerance test (FSIVGTT) and carotid intimal media thickness using carotid ultrasound. Following these measurements subjects will be randomized to receive pioglitazone or placebo and they will return every 3 months for determination of fasting plasma glucose (FPG) concentration and interim medical history. Recruitment will take place over 15 months. From the time that the recruitment period ends, subjects will be followed for a total of 24 months on pioglitazone or placebo. The OGTT will be repeated at 15,27, and 39 months, or if the FPG is ≥ 126 mg/dl on the 3-month follow up visits. If the diagnosis of diabetes is established before month 39 or at month 39, the FSIVGTT and carotid ultrasound will be repeated. At 39 months, subjects will be washed out of pioglitazone or placebo and the OGTT, FSIVGTT, and carotid ultrasound will be repeated at month 45.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220961

Locations
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
United States, California
USC-Keck School of Medicine
Los Angeles, California, United States, 90033
University of California San Diego-San Diego VA Medical Center
San Diego, California, United States, 92161
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
United States, New York
SUNY Health Science Center
Brooklyn, New York, United States, 11203
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Texas Diabetes Institute
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
Texas Diabetes Institute
University of Texas
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Ralph A. DeFronzo, M.D. Texas Diabetes Institute
  More Information

Additional Information:
No publications provided by Texas Diabetes Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00220961     History of Changes
Other Study ID Numbers: 02-062A
Study First Received: September 14, 2005
Last Updated: May 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Diabetes Institute:
Impaired Glucose Tolerance
Type 2 Diabetes
Prevention
Pioglitazone

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014