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

NCT00682448 | Completed Phase 4 Results

• 1 other identifier: 06122201
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Complications

Keywords

Olanzapine; Zyprexa; Weight Gain; Antipsychotics; Metformin; Glucophage; Bipolar Disorder; Schizophrenia; Depression; Diabetes; Side effects; Metabolic complications; Prevention; Treatment; Metabolic side effects of olanzapine

Outcome Measures

Primary Outcomes (1)

• Weight Gain

  Change from Baseline in weight

  Baseline and 6 months

Secondary Outcomes (1)

• Hemoglobin A1C

  Baseline and 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

Olanzapine plus Drug: Placebo. Subjects will remain on olanzapine plus placebo for 6 months.

Drug: Placebo

Interventions

Metformin DRUG

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.

Also known as: Glucophage, Fortamet, Riomet, Glumetza, Diabex, Diaformin

1

Placebo DRUG

Drug: Placebo. Subjects will remain on placebo for 6 months.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Weight Gain; Bipolar Disorder; Schizophrenia; Depression; Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Stephanie Cavanaugh, MD
• Organization: Rush University Medical Center

Stephanie_Cavanaugh@rush.edu

Study Officials

• Jeffrey T Rado, M.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Locations

US (1)