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)
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00231634
First received: September 30, 2005
Last updated: June 6, 2011
Last verified: January 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231634

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00231634     History of Changes
Other Study ID Numbers: CR002251
Study First Received: September 30, 2005
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Obesity
Type 2 Diabetes Mellitus
HbA1c
Sulfonylurea
Topiramate
Adult-Onset Diabetes Mellitus (AODM)

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on September 18, 2014