Metformin for the Prevention of the Metabolic Side-effects of Zyprexa
This study has been completed.
Sponsor:
Rush University Medical Center
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jeffrey Rado, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00682448
First received: May 20, 2008
Last updated: December 10, 2012
Last verified: December 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Complications |
Drug: Metformin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Metformin to Prevent the Metabolic Complications of Olanzapine |
Resource links provided by NLM:
Further study details as provided by Rush University Medical Center:
Primary Outcome Measures:
- Weight Gain and Insulin Resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dislipidemia, OGTT, Hemoglobin A1C [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | August 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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:
|
|
Placebo Comparator: 2
Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.
|
Drug: Placebo
Drug: Placebo. Subjects will remain on placebo for 6 months.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682448
Locations
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
Sponsors and Collaborators
Rush University Medical Center
Eli Lilly and Company
Investigators
| Principal Investigator: | Jeffrey T Rado, M.D. | Rush University Medical Center |
More Information
No publications provided
| Responsible Party: | Jeffrey Rado, MD, MD, Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00682448 History of Changes |
| Other Study ID Numbers: | 06122201 |
| Study First Received: | May 20, 2008 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rush University Medical Center:
|
Olanzapine Zyprexa Weight Gain Antipsychotics Metformin Glucophage Bipolar Disorder Schizophrenia |
Depression Diabetes Side effects Metabolic complications Prevention Treatment Metabolic side effects of olanzapine |
Additional relevant MeSH terms:
|
Metformin Olanzapine Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013