Actos Now for Prevention of Diabetes (ACT NOW)

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Ralph DeFronzo, MD, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00220961
First received: September 14, 2005
Last updated: June 29, 2016
Last verified: June 2016

September 14, 2005
June 29, 2016
January 2004
April 2010   (final data collection date for primary outcome measure)
Prevention of Type 2 Diabetes [ Time Frame: 2.4 years ] [ Designated as safety issue: No ]
Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization
Prevention of Type 2 Diabetes
Complete list of historical versions of study NCT00220961 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose of 2.4 Years [ Time Frame: Baseline versus 2.4 years ] [ Designated as safety issue: No ]
    Fasting Plasma Glucose
  • Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test [ Time Frame: Baseline versus 2.4 years ] [ Designated as safety issue: No ]
    Insulin secretion
  • Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values) [ Time Frame: Baseline versus 2.4 years ] [ Designated as safety issue: No ]
    Insulin sensitivity The Matsuda index was calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin), with higher numbers indicating better the insulin sensitivity.
  • Change in Atherosclerosis [ Time Frame: Baseline versus 2.4 years ] [ Designated as safety issue: No ]
    carotid intima thickness
  • 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
Not Provided
Not Provided
 
Actos Now for Prevention of Diabetes (ACT NOW)
Actos Now for Prevention of Diabetes (ACT NOW)
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
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Impaired Glucose Tolerance
  • Type 2 Diabetes
  • Drug: Pioglitazone
    Pioglitazone tablets - 45 mg/day
    Other Name: Actos
  • Drug: Placebo
    Placebo tablets similar to pioglitazone tablets - 1 tablet/day
  • Placebo Comparator: Placebo
    Placebo tablet similar to pioglitazone tablet
    Intervention: Drug: Placebo
  • Active Comparator: Pioglitazone
    Pioglitazone tablet similar to placebo tablet
    Intervention: Drug: Pioglitazone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
602
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00220961
02-062A
Not Provided
Not Provided
Not Provided
Ralph DeFronzo, MD, The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
  • University of Texas
  • Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Ralph A. DeFronzo, M.D. Texas Diabetes Institute
The University of Texas Health Science Center at San Antonio
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP