Actos Now for Prevention of Diabetes (ACT NOW) - Full Text View

Sponsor:	Texas Diabetes Institute
Collaborators:	University of Texas Takeda Pharmaceuticals North America, Inc.
Information provided by:	Texas Diabetes Institute
ClinicalTrials.gov Identifier:	NCT00220961

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 III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

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

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:

American Diabetes Association This link exits the ClinicalTrials.gov site

No publications provided by Texas Diabetes Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

DeFronzo RA, Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Hodis HN, Kitabchi AE, Mack WJ, Mudaliar S, Ratner RE, Williams K, Stentz FB, Musi N, Reaven PD; ACT NOW Study. Pioglitazone for diabetes prevention in impaired glucose tolerance. N Engl J Med. 2011 Mar 24;364(12):1104-15.

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 February 09, 2012