Trial Outcomes & Findings for Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus (NCT NCT00351000)

Results Overview

Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

baseline, week 6

Results posted on

2017-01-13

Participant Flow

Subjects will include 40 outpatients with schizophrenia or schizoaffective disorder treated with clozapine or olanzapine for at least one year. Twenty clozapine-treated subjects and twenty olanzapine-treated subjects with type 2 diabetes mellitus, impaired fasting glucose or insulin resistance will be recruited.

24 subjects consented for the study. Two subjects consented but were lost to follow-up, and one subject withdrew consent after receiving one dose of ziprasidone.

Participant milestones

Participant milestones
Measure	Open-label Ziprasidone All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
Overall Study STARTED	24
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ziprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Ziprasidone n=24 Participants All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49 years STANDARD_DEVIATION 8 • n=5 Participants
Gender Female	6 Participants n=5 Participants
Gender Male	18 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, week 6

Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting glucose levels from baseline to study endpoint (week 6 - baseline)

Outcome measures

Outcome measures
Measure	Clozapine Treatment With Adjunctive Ziprasidone n=11 Participants All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dosage will be unchanged during the trial.	Olanzapine Treatment With Adjunctive Ziprasidone n=10 Participants All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's olanzapine dosage will be unchanged during the trial.
Change From Baseline in Fasting Glucose	5 mg/dL Standard Deviation 3	-4.5 mg/dL Standard Deviation 9.1

PRIMARY outcome

Timeframe: baseline, week 6

Subjects on clozapine with adjunctive ziprasidone were compared to subjects on olanzapine with adjunctive ziprasidone on change in fasting insulin levels from baseline to study endpoint (week 6 - baseline)

Outcome measures

Outcome measures
Measure	Clozapine Treatment With Adjunctive Ziprasidone n=11 Participants All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dosage will be unchanged during the trial.	Olanzapine Treatment With Adjunctive Ziprasidone n=10 Participants All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's olanzapine dosage will be unchanged during the trial.
Change From Baseline on Fasting Insulin	1 microIU/L Standard Deviation 4.5	-0.9 microIU/L Standard Deviation 1.4

Adverse Events

Open-label Ziprasidone

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open-label Ziprasidone n=24 participants at risk All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
Cardiac disorders difficulty breathing	4.2% 1/24 • Number of events 1
General disorders dizziness	4.2% 1/24 • Number of events 1

Additional Information

Dr. David Henderson

Massachusetts General Hospital Schizophrenia Research Program

Phone: (617) 912-7800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place