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

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent change in body weight and change in Hemoglobin A1c (HbA1c) from baseline to Week 52.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Study Completion (ACTUAL)

November 1, 2002

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (ESTIMATE)

October 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002251

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on topiramate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe