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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
Results First Received: February 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Impaired Glucose Tolerance
Type 2 Diabetes
Interventions: Drug: Pioglitazone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo

Placebo tablet similar to pioglitazone tablet

Placebo: Placebo tablets similar to pioglitazone tablets - 1 tablet/day

Pioglitazone

Pioglitazone tablet similar to placebo tablet

Pioglitazone: Pioglitazone tablets - 45mg/day tablet


Participant Flow:   Overall Study
    Placebo   Pioglitazone
STARTED   299   303 
COMPLETED   228   213 
NOT COMPLETED   71   90 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Placebo tablet similar to pioglitazone tablet

Placebo: Placebo tablets similar to pioglitazone tablets

Pioglitazone

Pioglitazone tablet similar to placebo tablet

Pioglitazone: Pioglitazone tablets

Total Total of all reporting groups

Baseline Measures
   Placebo   Pioglitazone   Total 
Overall Participants Analyzed 
[Units: Participants]
 299   303   602 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   269   271   540 
>=65 years   30   32   62 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.3  (0.5)   52.3  (0.5)   52.3  (0.5) 
Gender 
[Units: Participants]
     
Female   126   127   253 
Male   173   176   349 
Region of Enrollment 
[Units: Participants]
     
United States   299   303   602 


  Outcome Measures
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1.  Primary:   Prevention of Type 2 Diabetes   [ Time Frame: 2.4 years ]

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

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

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

5.  Secondary:   Change in Atherosclerosis   [ Time Frame: Baseline versus 2.4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ralph DeFronzo, MD
Organization: University of Texas Health Science Center at San Antonio
phone: 210-567-6691
e-mail: defronzo@uthscsa.edu


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


Responsible Party: Ralph DeFronzo, MD, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00220961     History of Changes
Other Study ID Numbers: 02-062A
Study First Received: September 14, 2005
Results First Received: February 17, 2016
Last Updated: June 29, 2016
Health Authority: United States: Institutional Review Board