Trial Outcomes & Findings for GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes (NCT NCT00509223)
NCT ID: NCT00509223
Last Updated: 2013-12-30
Results Overview
Month 6 change in HbA1c (%)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
416 participants
Primary outcome timeframe
Baseline to Month 6
Results posted on
2013-12-30
Participant Flow
Subjects for this study were recruited from 15 medical clinics located in the United States and Australia.
Subjects were presented with an Informed Consent Form (and HIPAA in USA) and assessed for eligibility based on inclusion /exclusion criteria. If all IEC met, subjects randomized 1:1. 118 subjects not included in endpoint analysis due to reanalysis of Obstructive Sleep Apnea (OSA) inclusion criteria. 298 of the 416 were included for final analysis.
Participant milestones
| Measure |
Group 1
Lifestyle counseling with Positive Airway Pressure (PAP) therapy
Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.
Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep.
|
Group 2
Lifestyle counseling without Positive Airway Pressure (PAP) therapy
Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.
|
|---|---|---|
|
Overall Study
STARTED
|
207
|
209
|
|
Overall Study
COMPLETED
|
119
|
137
|
|
Overall Study
NOT COMPLETED
|
88
|
72
|
Reasons for withdrawal
| Measure |
Group 1
Lifestyle counseling with Positive Airway Pressure (PAP) therapy
Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.
Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep.
|
Group 2
Lifestyle counseling without Positive Airway Pressure (PAP) therapy
Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
25
|
6
|
|
Overall Study
Including: subject change of address
|
5
|
2
|
|
Overall Study
Did not meet revised inclusion criteria
|
56
|
62
|
Baseline Characteristics
GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Lifestyle Counseling With PAP Therapy
n=151 Participants
|
Lifestyle Counseling
n=147 Participants
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
84 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
67 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
59 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
97 participants
n=5 Participants
|
88 participants
n=7 Participants
|
185 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: The following definition was applied to the primary endpoint: included in analysis were all participants that had at least 1 follow-up HbA1c value in addition to the Baseline HbA1c were considered.
Month 6 change in HbA1c (%)
Outcome measures
| Measure |
Lifestyle Counseling With PAP Therapy
n=129 Participants
|
Lifestyle Counseling
n=138 Participants
|
|---|---|---|
|
HbA1c Change
|
-0.1 HbA1c percent
Standard Deviation 0.8
|
-0.1 HbA1c percent
Standard Deviation 0.7
|
Adverse Events
Lifestyle Counseling
Serious events: 5 serious events
Other events: 78 other events
Deaths: 0 deaths
Lifestyle Counseling With PAP Therapy
Serious events: 10 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lifestyle Counseling
n=147 participants at risk
|
Lifestyle Counseling With PAP Therapy
n=151 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
GI Distress
|
0.00%
0/147
|
0.66%
1/151 • Number of events 1
|
|
General disorders
Headache
|
0.68%
1/147 • Number of events 1
|
0.00%
0/151
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/147
|
0.66%
1/151 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.68%
1/147 • Number of events 1
|
0.66%
1/151 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/147
|
0.66%
1/151 • Number of events 1
|
|
Surgical and medical procedures
Procedure
|
1.4%
2/147 • Number of events 2
|
1.3%
2/151 • Number of events 2
|
|
Cardiac disorders
TIA / Blockage of Artery
|
0.00%
0/147
|
1.3%
2/151 • Number of events 2
|
|
Reproductive system and breast disorders
Ovarian Cancer
|
0.68%
1/147 • Number of events 1
|
0.00%
0/151
|
|
Nervous system disorders
Brachial Plexopathy
|
0.00%
0/147
|
0.66%
1/151 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/147
|
0.66%
1/151 • Number of events 1
|
Other adverse events
| Measure |
Lifestyle Counseling
n=147 participants at risk
|
Lifestyle Counseling With PAP Therapy
n=151 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
GI Distress
|
3.4%
5/147
|
6.0%
9/151
|
|
Blood and lymphatic system disorders
General Infection
|
5.4%
8/147
|
4.0%
6/151
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness/Irritation
|
2.0%
3/147
|
6.6%
10/151
|
|
Musculoskeletal and connective tissue disorders
Pain
|
11.6%
17/147
|
7.3%
11/151
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
7.5%
11/147
|
12.6%
19/151
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
23.1%
34/147
|
25.8%
39/151
|
Additional Information
Jonathan Shaw, MD, FRACP, FRCP
Baker IDI Heart and Diabetes Institute
Phone: +61 (0) 3 8532 1821
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60