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

This study has been terminated.
(Program discontinued)
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier:
First received: September 30, 2005
Last updated: June 6, 2011
Last verified: January 2011
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Drug: topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Topiramate in the Treatment of Obese, Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy

Resource links provided by NLM:

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Percent change in body weight and change in Hemoglobin A1c (HbA1c) from baseline to Week 52.

Secondary Outcome Measures:
  • Change from baseline to Week 52 in BMI, FPG; safety evaluations (adverse events, hypoglycemic events) throughout study.

Enrollment: 31
Study Start Date: May 2001
Study Completion Date: November 2002
Detailed Description:
Topiramate is a medication for the treatment of seizures, but not approved for the treatment of obesity. This is a randomized, double-blind, placebo controlled study to evaluate the effectiveness and safety of topiramate in Type 2 diabetic patients with obesity who have failed on treatment with sulfonylurea. After a 4-week enrollment phase and 8-week titration phase, patients receive either topiramate (96, 192, or 256 mg twice daily) or placebo for 44 weeks, followed by a 6-week follow-up phase. Assessments of effectiveness include body weight, hemoglobin type A1c [HbA1c] (a measurement of average blood sugar level over several months), Body Mass Index (BMI), fasting plasma glucose (FPG) level, fasting lipid profile, fasting insulin, uric acid level, blood pressures, and health related quality of life (HRQOL) measures. Safety evaluations, including incidence and severity of adverse events, hypoglycemic episodes, clinical laboratory results such as the liver enzymes, and vital signs, are performed throughout the study. The study hypothesis is that topiramate will be effective in the treatment of type 2 diabetes through weight reduction. During the initial 8-weeks, oral doses taken twice daily of topiramate or placebo will be gradually increased to target doses (either 96 milligrams[mg], 192mg, or 256mg daily); the dose will be maintained for 44 weeks.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00231634

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information: Identifier: NCT00231634     History of Changes
Other Study ID Numbers: CR002251
Study First Received: September 30, 2005
Last Updated: June 6, 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Type 2 Diabetes Mellitus
Adult-Onset Diabetes Mellitus (AODM)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents processed this record on April 28, 2017