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Trial record 1 of 1 for:    NCT00220961
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Actos Now for Prevention of Diabetes (ACT NOW)

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ClinicalTrials.gov Identifier: NCT00220961
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : August 11, 2016
Last Update Posted : August 11, 2016
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

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

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Type 2 Diabetes Drug: Pioglitazone Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Actos Now for Prevention of Diabetes (ACT NOW)
Study Start Date : January 2004
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo tablet similar to pioglitazone tablet
Drug: Placebo
Placebo tablets similar to pioglitazone tablets - 1 tablet/day

Active Comparator: Pioglitazone
Pioglitazone tablet similar to placebo tablet
Drug: Pioglitazone
Pioglitazone tablets - 45 mg/day
Other Name: Actos

Primary Outcome Measures :
  1. Prevention of Type 2 Diabetes [ Time Frame: 2.4 years ]
    Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization

Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose of 2.4 Years [ Time Frame: Baseline versus 2.4 years ]
    Fasting Plasma Glucose

  2. Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test [ Time Frame: Baseline versus 2.4 years ]
    Insulin secretion

  3. Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values) [ Time Frame: Baseline versus 2.4 years ]
    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.

  4. Change in Atherosclerosis [ Time Frame: Baseline versus 2.4 years ]
    carotid intima thickness

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220961

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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
The University of Texas Health Science Center at San Antonio
University of Texas
Takeda Pharmaceuticals North America, Inc.
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Principal Investigator: Ralph A. DeFronzo, M.D. Texas Diabetes Institute
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ralph DeFronzo, MD, Professor of Medicine, Chief of Diabetes, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00220961    
Other Study ID Numbers: 02-062A
First Posted: September 22, 2005    Key Record Dates
Results First Posted: August 11, 2016
Last Update Posted: August 11, 2016
Last Verified: June 2016
Keywords provided by Ralph DeFronzo, MD, The University of Texas Health Science Center at San Antonio:
Impaired Glucose Tolerance
Type 2 Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs