Trial Outcomes & Findings for Metformin for the Prevention of the Metabolic Side-effects of Zyprexa (NCT NCT00682448)

NCT ID: NCT00682448

Last Updated: 2021-02-02

Results Overview

Change from Baseline in weight

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2021-02-02

Participant Flow

Participant milestones

Measure	Metformin Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.	Placebo Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months. Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months.
Overall Study STARTED	12	13
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Metformin Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.	Placebo Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months. Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months.
Overall Study Adverse Event	1	2
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	1	3
Overall Study Pregnancy	0	1
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Metformin for the Prevention of the Metabolic Side-effects of Zyprexa

Baseline characteristics by cohort

Measure	Metformin n=12 Participants Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.	Placebo n=13 Participants Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months. Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	33.5 years STANDARD_DEVIATION 10.12 • n=93 Participants	39.08 years STANDARD_DEVIATION 8.62 • n=4 Participants	36.4 years STANDARD_DEVIATION 9.6 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Race/Ethnicity, Customized White	7 participants n=93 Participants	3 participants n=4 Participants	12 participants n=27 Participants
Race/Ethnicity, Customized African American	4 participants n=93 Participants	8 participants n=4 Participants	12 participants n=27 Participants
Race/Ethnicity, Customized Other	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants
Region of Enrollment United States	12 participants n=93 Participants	13 participants n=4 Participants	27 participants n=27 Participants
weight	84.51 kilogram STANDARD_DEVIATION 16.56 • n=93 Participants	95.59 kilogram STANDARD_DEVIATION 34.44 • n=4 Participants	90.33 kilogram STANDARD_DEVIATION 27.39 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: intent to treat using last observation carried forward. Only subjects with one observation post-baseline were included in the analysis.

Change from Baseline in weight

Outcome measures

Measure	Metformin n=12 Participants Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.	Placebo n=13 Participants Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months. Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months.
Weight Gain	2.54 kilogram Standard Deviation 2.35	5.88 kilogram Standard Deviation 5.23

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: total of 18 participants reflects the number of participants with available data at 6 months.

change from baseline in hemoglobin AIC

Outcome measures

Measure	Metformin n=10 Participants Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.	Placebo n=8 Participants Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months. Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months.
Hemoglobin A1C	0.05 % HbAIC Standard Deviation 0.28	0.1 % HbAIC Standard Deviation 0.26

Adverse Events

Metformin

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metformin n=12 participants at risk Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.	Placebo n=13 participants at risk Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months. Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months.
Psychiatric disorders suicidal ideation	0.00% 0/12 • 6 months	15.4% 2/13 • Number of events 2 • 6 months
Respiratory, thoracic and mediastinal disorders Respiratory infection	8.3% 1/12 • Number of events 1 • 6 months	0.00% 0/13 • 6 months

Other adverse events

Measure	Metformin n=12 participants at risk Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months. Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.	Placebo n=13 participants at risk Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months. Placebo: Drug: Placebo. Subjects will remain on placebo for 6 months.
Psychiatric disorders sedation	25.0% 3/12 • Number of events 3 • 6 months	23.1% 3/13 • Number of events 3 • 6 months
Endocrine disorders Dry mouth	25.0% 3/12 • Number of events 3 • 6 months	38.5% 5/13 • Number of events 5 • 6 months
Gastrointestinal disorders stomach upset	25.0% 3/12 • Number of events 3 • 6 months	46.2% 6/13 • Number of events 6 • 6 months
Nervous system disorders headache	25.0% 3/12 • Number of events 3 • 6 months	7.7% 1/13 • Number of events 1 • 6 months
Endocrine disorders hypoglycemia	8.3% 1/12 • Number of events 1 • 6 months	0.00% 0/13 • 6 months

Additional Information

Stephanie Cavanaugh, MD

Rush University Medical Center

Email: Stephanie_Cavanaugh@rush.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place