Trial Outcomes & Findings for Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment (NCT NCT00337350)
NCT ID: NCT00337350
Last Updated: 2015-05-08
Results Overview
Insulin Sensitivity (IS) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in IS between Baseline and week 8. SI was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SI represents the increase in net fractional glucose clearance rate per unit change in serum insulin concentration after the intravenous glucose load (microUnits/mL).
COMPLETED
PHASE4
20 participants
baseline, week 8
2015-05-08
Participant Flow
Subjects were recruited from the Freedom Trial Clinic at the Erich Lindemann Mental Health Center and were studied at the Mallinckrodt General Clinical Research Center (GCRC) at Massachusetts General Hospital (MGH), Boston.
Participant milestones
| Measure |
Rosiglitazone
rosiglitazone 4mg/day
|
Placebo
matched placebo for rosiglitazone 4mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment
Baseline characteristics by cohort
| Measure |
Rosiglitazone
n=9 Participants
rosiglitazone 4mg/day
|
Placebo
n=11 Participants
matched placebo for rosiglitazone 4mg/day
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
41.11 years
STANDARD_DEVIATION 10.29 • n=99 Participants
|
39.36 years
STANDARD_DEVIATION 7.06 • n=107 Participants
|
40.15 years
STANDARD_DEVIATION 8.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
11 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, week 8Insulin Sensitivity (IS) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in IS between Baseline and week 8. SI was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SI represents the increase in net fractional glucose clearance rate per unit change in serum insulin concentration after the intravenous glucose load (microUnits/mL).
Outcome measures
| Measure |
Rosiglitazone
n=8 Participants
rosiglitazone 4mg/day
|
Placebo
n=10 Participants
matched placebo for rosiglitazone 4mg/day
|
|---|---|---|
|
Change From Baseline in Insulin Sensitivity
|
3.2 microUnits/mL
Standard Deviation 3.9
|
0.4 microUnits/mL
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: baseline, week 8Glucose utilization (SG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. SG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. SG represents the net fractional glucose clearance rate because of the increase in glucose independent of any increase in circulating insulin concentrations above baseline.
Outcome measures
| Measure |
Rosiglitazone
n=8 Participants
rosiglitazone 4mg/day
|
Placebo
n=10 Participants
matched placebo for rosiglitazone 4mg/day
|
|---|---|---|
|
Change From Baseline on Glucose Utilization (SG)
|
.002 min^-1
Standard Deviation .002
|
-0.01 min^-1
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: baseline, week 8Acute insulin response to glucose (AIRG) was assessed using a Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT), performed at Baseline and at week 8 (study endpoint). Subjects in the Rosiglitazone treatment arm were compared to subjects in the placebo treatment arm on their change in SG between Baseline and week 8. AIRG was calculated from plasma glucose and serum insulin values using the MINMOD Millennium computer program. AIRG measures the acute(0-10 min) beta\\ cell response to a glucose load calculated by the areas under the curve higher than basal insulin values. The AIRG was assessed as the incremental area under the curve (calculated by the trapezoid rule) from 0 to 10 min of the FSIVGTT.
Outcome measures
| Measure |
Rosiglitazone
n=8 Participants
rosiglitazone 4mg/day
|
Placebo
n=10 Participants
matched placebo for rosiglitazone 4mg/day
|
|---|---|---|
|
Change From Baseline in Acute Insulin Response to Glucose (AIRG)
|
-151 Units/mL per 10 minutes
Standard Deviation 457
|
19 Units/mL per 10 minutes
Standard Deviation 22
|
Adverse Events
Rosiglitazone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Henderson
Massachusetts General Hospital Schizophrenia Research Program
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place