Metformin for the Prevention of the Metabolic Side-effects of Zyprexa
|ClinicalTrials.gov Identifier: NCT00682448|
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : December 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Complications||Drug: Metformin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Metformin to Prevent the Metabolic Complications of Olanzapine|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Active Comparator: 1
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.
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 Comparator: 2
Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.
Drug: Placebo. Subjects will remain on placebo for 6 months.
- Weight Gain and Insulin Resistance [ Time Frame: 6 months ]
- Dislipidemia, OGTT, Hemoglobin A1C [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682448
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Jeffrey T Rado, M.D.||Rush University Medical Center|