Trial Outcomes & Findings for Rosiglitazone Effect on Mitochondria and Lipoatrophy (NCT NCT00367744)
NCT ID: NCT00367744
Last Updated: 2017-02-06
Results Overview
Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
48 weeks
Results posted on
2017-02-06
Participant Flow
Recruited at Case Western Reserve University and Cleveland Clinic. Recruitment occurred between from July 2006 (first subject was randomized) to December 2007 (last subject was randomized).
A total of 71 subjects were randomized. Results are reported for 71 subjects.
Participant milestones
| Measure |
Rosiglitazone
Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks)
|
Placebo
Placebo arm for the whole duration of the study
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
37
|
|
Overall Study
COMPLETED
|
30
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Rosiglitazone
Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks)
|
Placebo
Placebo arm for the whole duration of the study
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
Baseline Characteristics
Rosiglitazone Effect on Mitochondria and Lipoatrophy
Baseline characteristics by cohort
| Measure |
Rosiglitazone
n=34 Participants
Rosiglitazone 4mg daily for 4 weeks then the dose increased to 4mg twice daily for the remainder of the study (44 weeks)
|
Placebo
n=37 Participants
Placebo arm
|
Total
n=71 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
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 7 • n=5 Participants
|
50 years
STANDARD_DEVIATION 7 • n=7 Participants
|
49.04 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Gender
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
37 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
CD4+ cell count
|
596 cells/mm3
n=5 Participants
|
691 cells/mm3
n=7 Participants
|
645.5 cells/mm3
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Intention to treat analysis with last observation carried forward if week 48 limb fat data was missing and post-baseline limb fat was availble.
Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
Outcome measures
| Measure |
Rosiglitazone
n=34 Participants
Rosiglitazone 4mg daily for 4 weeks then BID for 44 weeks
|
Placebo
n=37 Participants
Placebo arm
|
|---|---|---|
|
Change in Limb Fat at 48 Weeks
|
448 grams
Interval 138.0 to 1670.0
|
153 grams
Interval -100.0 to 682.0
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Intention to treat analysis with last observation carried forward if week 48 carotid IMT data was missing and post-baseline IMT data was available
Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups.
Outcome measures
| Measure |
Rosiglitazone
n=30 Participants
Rosiglitazone 4mg daily for 4 weeks then BID for 44 weeks
|
Placebo
n=32 Participants
Placebo arm
|
|---|---|---|
|
the Change in the Carotid IMT of the Common Carotid Artery
|
0.10 mm
Interval -0.05 to 0.25
|
0.15 mm
Interval 0.0 to 0.25
|
Adverse Events
Rosiglitazone
Serious events: 15 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosiglitazone
n=34 participants at risk
Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
|
Placebo
n=37 participants at risk
Placebo arm
|
|---|---|---|
|
Cardiac disorders
Elevated Cholesterol (Grade 2 or 3)
|
11.8%
4/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
16.2%
6/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Blood and lymphatic system disorders
Elevated Triglycerides (Grade 2)
|
11.8%
4/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Vascular disorders
Elevated LDL Cholesterol (Grade 2 or 3)
|
0.00%
0/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
10.8%
4/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Vascular disorders
Elevated Blood Pressure (Grade 2 or 3)
|
14.7%
5/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
5.4%
2/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Blood and lymphatic system disorders
Low ANC (Grade 2)
|
5.9%
2/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Musculoskeletal and connective tissue disorders
Low Phosphate (Grade 2 or 3)
|
11.8%
4/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
5.4%
2/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Blood and lymphatic system disorders
Elevated Creatinine (Grade 2)
|
20.6%
7/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
18.9%
7/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Cardiac disorders
Irregular Pulse
|
2.9%
1/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
0.00%
0/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Hepatobiliary disorders
Elevated AST (Grade 2)
|
0.00%
0/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Hepatobiliary disorders
Elevated ALT
|
2.9%
1/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Cardiac disorders
Angina
|
2.9%
1/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
0.00%
0/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Blood and lymphatic system disorders
Elevated Glucose (Grade 2)
|
2.9%
1/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
0.00%
0/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Blood and lymphatic system disorders
Decreased Platelets (Grade 2 or 3)
|
2.9%
1/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
0.00%
0/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Psychiatric disorders
Depression (Grade 2)
|
0.00%
0/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Psychiatric disorders
Suicidal Gesture (Grade 4)
|
0.00%
0/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
Other adverse events
| Measure |
Rosiglitazone
n=34 participants at risk
Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
|
Placebo
n=37 participants at risk
Placebo arm
|
|---|---|---|
|
Metabolism and nutrition disorders
Low Fasting Glucose (Grade 1)
|
2.9%
1/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
0.00%
0/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Musculoskeletal and connective tissue disorders
Low Phosphate (Grade 2)
|
14.7%
5/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
13.5%
5/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Blood and lymphatic system disorders
Elevated Bilirubin (Grade 2 or 3)
|
0.00%
0/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
|
Musculoskeletal and connective tissue disorders
Elevated Creatine Kinase (Grade 2)
|
0.00%
0/34 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
2.7%
1/37 • weeks 2,4,12,18,24,36 and 48
assessment for adverse events were done at study visits (weeks 24, and 48) additional safety visits occurred at weeks 2,4,12,18 and 36
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place