A Study of the Efficacy and Safety of Topiramate in Obese, Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy

• Status: Terminated
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness and safety of topiramate with placebo in the treatment of obesity and Type 2 diabetes mellitus in patients who have failed on sulfonylurea therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Diagnosis of Type 2 Diabetes, receiving only second generation sulfonylurea therapy (may include: glipizide, gliclazide, glimepiride, glibenclamide/glyburide, and gliquadone) for at least 4 months and on stable dose for at least 2 months

• Body Mass Index >= 27 and < 50

• HbA1c < 11% at enrollment

• Diagnosed hypertension or hyperlipidemia must be controlled

• Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

• Known contraindication or hypersensitivity to topiramate or sulfonylurea therapy

• Pregnancy or women who are nursing or plan to become pregnant during the study

• Diagnosed with Type 1 diabetes

• History of severe or recurrent hypoglycemic episodes

• Treatment with any antidiabetic agent other than sulfonylurea