Metformin for the Prevention of the Metabolic Side-effects of Zyprexa
Overview[ - collapse ][ - ]
Purpose | We hypothesize that metformin co-administered with olanzapine will be well tolerated and associated with significantly less insulin resistance, weight gain and dyslipidemia as compared to olanzapine plus placebo. |
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Condition | Metabolic Complications |
Intervention | Drug: Metformin Drug: Placebo |
Phase | Phase 4 |
Sponsor | Rush University Medical Center |
Responsible Party | Rush University Medical Center |
ClinicalTrials.gov Identifier | NCT00682448 |
First Received | May 20, 2008 |
Last Updated | December 10, 2012 |
Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | May 20, 2008 |
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Last Updated Date | December 10, 2012 |
Start Date | August 2007 |
Estimated Primary Completion Date | August 2011 |
Current Primary Outcome Measures | Weight Gain and Insulin Resistance [Time Frame: 6 months] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Dislipidemia, OGTT, Hemoglobin A1C [Time Frame: 6 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Metformin for the Prevention of the Metabolic Side-effects of Zyprexa |
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Official Title | Metformin to Prevent the Metabolic Complications of Olanzapine |
Brief Summary | We hypothesize that metformin co-administered with olanzapine will be well tolerated and associated with significantly less insulin resistance, weight gain and dyslipidemia as compared to olanzapine plus placebo. |
Detailed Description | Increased risk of metabolic complications with olanzapine therapy, relative to other antipsychotics, may lead clinicians to avoid its use, despite evidence of greater efficacy. These problems may also pose a therapeutic dilemma for patients who respond well to olanzapine. Metabolic complications negatively impact on morbidity and mortality, impair quality of life and increase illness relapse secondary to medication non-compliance. Thus far, no pharmacologic agent co-administered with olanzapine has proven effective at preventing these untoward effects. The present study proposes to examine the efficacy and safety of metformin to attenuate the metabolic side effects associated with olanzapine. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
Condition | Metabolic Complications |
Intervention | Drug: 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. Other Names:
Drug: Placebo. Subjects will remain on placebo for 6 months. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 27 |
Estimated Completion Date | August 2011 |
Estimated Primary Completion Date | August 2011 |
Eligibility Criteria | Inclusion Criteria: - Diagnosis of: Schizophrenia, Schizoaffective Disorder, Bipolar I or II or major depression with psychotic features who will be started on or who have just started taking Olanzapine (Zyprexa). Exclusion Criteria: - Patients with either a history of diabetes mellitus or a baseline FBG>126 or two random blood sugars of > 200 or during a OGTT glucose level of > 200 two hours after a glucose load of 50 grams. (All American Diabetes Association criteria for diabetes mellitus). - Baseline liver function tests (SGOT, SGPT, AP) greater than 3X normal. - Chronic alcoholism - MDRD less than 60 ml/1.73 m2. Modification of Diet in Renal Disease (MDRD) Equation estimates the glomerular filtration rate as a measure of kidney function. This equation takes into account the plasma creatinine, age, race and gender, and is a more accurate estimation of glomerular filtration rate than serum creatinine alone. - Patients with unstable medical problems, including cardiovascular instability or significant congestive heart failure (as determined by study investigators). - Prolonged QTc greater than 430 ms on baseline EKG. - History of lactic acidosis. - History of hypoglycemia. - Current treatment with metformin or other antidiabetic agents. - Treatment with any antihyperlipidemic medication within 3 months of randomization. - Treatment with olanzapine or clozapine within 3 months of randomization. - Concurrent treatment with ziprasidone, risperidone, quetiapine or aripiprazole or any other neuroleptic medication. - Concurrent use of OTC chromium, gymnema or cimetidine will be prohibited. Patient may discontinue these medications up to one day prior to randomization. - Current treatment with corticosteroids. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00682448 |
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Other Study ID Numbers | 06122201 |
Has Data Monitoring Committee | No |
Information Provided By | Rush University Medical Center |
Study Sponsor | Rush University Medical Center |
Collaborators | Eli Lilly and Company |
Investigators | Principal Investigator: Jeffrey T Rado, M.D. Rush University Medical Center |
Verification Date | December 2012 |
Locations[ + expand ][ + ]
Rush University Medical Center | Chicago, Illinois, United States, 60612 |
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