GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509223
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : October 17, 2013
Last Update Posted : December 30, 2013
Royal North Shore Hospital
Baker IDI Heart and Diabetes Institute
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus Type 2
Interventions: Device: Positive Airway Pressure therapy
Behavioral: Lifestyle counseling

  Participant Flow

  Baseline Characteristics

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.
118 subjects (of the 416 that started in the participant flow module) were not included in endpoint analysis due to reanalysis of OSA inclusion criteria. Thus, 298 of the 416 were included for final analysis.

Reporting Groups
Lifestyle Counseling With PAP Therapy No text entered.
Lifestyle Counseling No text entered.
Total Total of all reporting groups

Baseline Measures
   Lifestyle Counseling With PAP Therapy   Lifestyle Counseling   Total 
Overall Participants Analyzed 
[Units: Participants]
 151   147   298 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   84   90   174 
>=65 years   67   57   124 
[Units: Years]
Mean (Standard Deviation)
 62.4  (9.1)   62.1  (9.0)   62.3  (9.0) 
[Units: Participants]
Female   52   54   106 
Male   99   93   192 
Region of Enrollment 
[Units: Participants]
United States   54   59   113 
Australia   97   88   185 

  Outcome Measures

1.  Primary:   HbA1c Change   [ Time Frame: Baseline to Month 6 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Jonathan Shaw, MD, FRACP, FRCP
Organization: Baker IDI Heart and Diabetes Institute
phone: +61 (0) 3 8532 1821

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

Responsible Party: ResMed Identifier: NCT00509223     History of Changes
Other Study ID Numbers: CA-09-06-01
First Submitted: July 29, 2007
First Posted: July 31, 2007
Results First Submitted: August 8, 2013
Results First Posted: October 17, 2013
Last Update Posted: December 30, 2013