Actos Now for Prevention of Diabetes (ACT NOW)
1 other identifier
interventional
602
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2004
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
August 11, 2016
CompletedAugust 11, 2016
June 1, 2016
6.3 years
September 14, 2005
February 17, 2016
June 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention of Type 2 Diabetes
Percentage of Participants with Type 2 Diabetes at 2.4 years Post-randomization
2.4 years
Secondary Outcomes (4)
Change From Baseline in Fasting Plasma Glucose of 2.4 Years
Baseline versus 2.4 years
Change From Baseline in Plasma Insulin Concentration During Oral Glucose Tolerance Test
Baseline versus 2.4 years
Change From Baseline in Matsuda Index of Insulin Sensitivity (There Are no Minimum/Maximum Values)
Baseline versus 2.4 years
Change in Atherosclerosis
Baseline versus 2.4 years
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo tablet similar to pioglitazone tablet
Pioglitazone
ACTIVE COMPARATORPioglitazone tablet similar to placebo tablet
Interventions
Eligibility Criteria
You may qualify if:
- Men and women
- All ethnic groups
- 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)
You may not qualify if:
- 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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
USC-Keck School of Medicine
Los Angeles, California, 90033, United States
University of California San Diego-San Diego VA Medical Center
San Diego, California, 92161, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
SUNY Health Science Center
Brooklyn, New York, 11203, United States
University of Tennessee
Memphis, Tennessee, 38163, United States
Texas Diabetes Institute
San Antonio, Texas, 78207, United States
Related Publications (7)
Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
PMID: 33210751DERIVEDTripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Reaven PD, DeFronzo RA. Diabetes Incidence and Glucose Tolerance after Termination of Pioglitazone Therapy: Results from ACT NOW. J Clin Endocrinol Metab. 2016 May;101(5):2056-62. doi: 10.1210/jc.2015-4202. Epub 2016 Mar 16.
PMID: 26982008DERIVEDTripathy D, Cobb JE, Gall W, Adam KP, George T, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Reaven PD, Musi N, Ferrannini E, DeFronzo RA. A novel insulin resistance index to monitor changes in insulin sensitivity and glucose tolerance: the ACT NOW study. J Clin Endocrinol Metab. 2015 May;100(5):1855-62. doi: 10.1210/jc.2014-3824. Epub 2015 Jan 20.
PMID: 25603459DERIVEDTripathy D, Clement SC, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Gastaldelli A, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Reaven PD, DeFronzo RA. Baseline adiponectin levels do not influence the response to pioglitazone in ACT NOW. Diabetes Care. 2014 Jun;37(6):1706-11. doi: 10.2337/dc13-1745. Epub 2014 Apr 4.
PMID: 24705615DERIVEDSaremi A, Schwenke DC, Buchanan TA, Hodis HN, Mack WJ, Banerji M, Bray GA, Clement SC, Henry RR, Kitabchi AE, Mudaliar S, Ratner RE, Stentz FB, Musi N, Tripathy D, DeFronzo RA, Reaven PD. Pioglitazone slows progression of atherosclerosis in prediabetes independent of changes in cardiovascular risk factors. Arterioscler Thromb Vasc Biol. 2013 Feb;33(2):393-9. doi: 10.1161/ATVBAHA.112.300346. Epub 2012 Nov 21.
PMID: 23175674DERIVEDDeFronzo 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. doi: 10.1056/NEJMoa1010949.
PMID: 21428766DERIVEDDefronzo RA, Banerji M, Bray GA, Buchanan TA, Clement S, Henry RR, Kitabchi AE, Mudaliar S, Musi N, Ratner R, Reaven PD, Schwenke D, Stentz FB, Tripathy D. Actos Now for the prevention of diabetes (ACT NOW) study. BMC Endocr Disord. 2009 Jul 29;9:17. doi: 10.1186/1472-6823-9-17.
PMID: 19640291DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ralph DeFronzo, MD
- Organization
- University of Texas Health Science Center at San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph A. DeFronzo, M.D.
Texas Diabetes Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Chief of Diabetes
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
January 1, 2004
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
August 11, 2016
Results First Posted
August 11, 2016
Record last verified: 2016-06