Actos Now for the prevention of diabetes (ACT NOW) study
1 Texas Diabetes Institute and University of Texas Health Science Center, San Antonio, TX, USA
2 Suny Health Science Center at Brooklyn, Brooklyn, NY, USA
3 Pennington Biomedical Research Center/LSU, Baton Rouge, LA, USA
4 University of Southern California Keck School of Medicine, Los Angeles, CA, USA
5 Division of Endocrinology & Metabolism, Georgetown University, Washington, DC, USA
6 VA San Diego Healthcare System and University of California at San Diego, USA
7 University of Tennessee, Division of Endocrinology, Diabetes and Metabolism, Memphis, TN, USA
8 Medstar Research Institute, Hyattsville, MD, USA
9 Phoenix VA Health Care System, Phoenix, AZ and W.P. Carey School of Business, Arizona State University, Tempe, AZ, USA
BMC Endocrine Disorders 2009, 9:17 doi:10.1186/1472-6823-9-17Published: 29 July 2009
Impaired glucose tolerance (IGT) is a prediabetic state. If IGT can be prevented from progressing to overt diabetes, hyperglycemia-related complications can be avoided. The purpose of the present study was to examine whether pioglitazone (ACTOS®) can prevent progression of IGT to type 2 diabetes mellitus (T2DM) in a prospective randomized, double blind, placebo controlled trial.
602 IGT subjects were identified with OGTT (2-hour plasma glucose = 140–199 mg/dl). In addition, IGT subjects were required to have FPG = 95–125 mg/dl and at least one other high risk characteristic. Prior to randomization
Primary endpoint is conversion of IGT to T2DM based upon FPG ≥ 126 or 2-hour PG ≥ 200 mg/dl. Secondary endpoints include whether pioglitazone can: (i) improve glycemic control (ii) enhance insulin sensitivity, (iii) augment beta cell function, (iv) improve risk factors for cardiovascular disease, (v) cause regression/slow progression of carotid IMT, (vi) revert newly diagnosed diabetes to normal glucose tolerance.
ACT NOW is designed to determine if pioglitazone can prevent/delay progression to diabetes in high risk IGT subjects, and to define the mechanisms (improved insulin sensitivity and/or enhanced beta cell function) via which pioglitazone exerts its beneficial effect on glucose metabolism to prevent/delay onset of T2DM.
clinical trials.gov identifier: NCT00220961