Phase 4
Completed N=25
Metformin for the Prevention of the Metabolic Side-effects of Zyprexa
Metabolic Complications
Source: ClinicalTrials.gov NCT00682448 ↗
Enrolled (actual)
25
Serious AEs
12.0%
Results posted
Feb 2021
Primary outcomePrimary: Weight Gain — 2.54; 5.88 kilogram
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Gain |
2.54; 5.88 | — |
| SECONDARY Hemoglobin A1C |
0.05; 0.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00682448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.