A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00231660
First received: September 30, 2005
Last updated: June 6, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to compare the efficacy (in terms of weight and hemoglobin type A1c [HbA1c]) and safety of topiramate (96 milligrams[mg] or 192 mg daily) with placebo in the treatment of obesity in Type 2 diabetic patients receiving metformin.


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 Treated With Metformin

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The percent change in body weight and change in HbA1c from baseline (Week 0) to one year after maintenance therapy (Week 60).

Secondary Outcome Measures:
  • Changes from baseline or from enrollment to Week 60 in BMI and HRQOL measures; safety evaluations, such as adverse events and vital signs throughout study.

Enrollment: 211
Study Start Date: October 2000
Study Completion Date: June 2002
Detailed Description:

Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study is designed to assess the efficacy and safety of topiramate in Type 2 diabetic patients with obesity who are well-controlled on metformin alone. Patients are randomized to receive either topiramate (up to a target dose of 96 or 192 mg per day) or placebo for one year. Assessments of efficacy include weight reduction, levels of HbA1c (shows average blood sugar level over a few months), Body Mass Index (BMI), and Health Related Quality of Life (HRQOL) measures. Safety evaluations (incidence of adverse events, vital signs, hypoglycemic events, electrocardiograms [ECGs], clinical laboratory values) are monitored throughout the study. The study hypothesis is that topiramate, combined with metformin and non-pharmacologic therapy, can effectively achieve significant weight reduction and is well tolerated. During the first 8 weeks, oral doses of matching placebo or topiramate are increased gradually to target dose (96 milligrams[mg] or 192mg daily); the dose will be maintained for 1 year, then gradually reduced and stopped

  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 and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment
  • Metformin total daily dose not to exceed 2.1 grams/day
  • Body Mass Index >= 27 and < 50
  • HbA1c < 11%
  • Fasting plasma glucose >= 126 and < 240
  • Stable weight
  • Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

  • Known contraindication, or hypersensitivity to topiramate
  • Use of other antidiabetic medications within the last 4 months
  • Excessive weight loss
  • Diagnosis of type 1 diabetes
  • History of severe or recurrent hypoglycemic episodes
  • Severe pulmonary disease
  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: NCT00231660

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: NCT00231660     History of Changes
Other Study ID Numbers: CR003718
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.:
Type 2 Diabetes
Obesity
Metformin
Hemoglobin A1c
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
Metformin
Topiramate
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on October 01, 2014