A Study of the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236626
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to investigate (1) the effect of topiramate on insulin sensitivity in overweight or obese patients with type 2 diabetes mellitus and (2) the safety of topiramate in type 2 diabetic patients. The study will also investigate the effect of topiramate on body weight, body fat, fat distribution, and metabolic control including both glucose and lipid levels.


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

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 9 Month, Double-Blind, Placebo-Controlled Study With a Blinded Crossover Transition to Open-Label Extension, Evaluating the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Type 2 Diabetes Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean change in insulin sensitivity from baseline to Month 9.

Secondary Outcome Measures:
  • Mean change, baseline to Month 9, in body weight and composition, Body Mass Index (BMI), lipid profile, fasting glucose; blood pressure; safety evaluations (adverse events) during study.

Enrollment: 38
Study Start Date: April 2000
Study Completion Date: May 2002
Detailed Description:

Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study investigates the effect of topiramate on insulin sensitivity in overweight or obese patients with Type 2 Diabetes. After a screening phase, patients are randomized to receive either topiramate (96 milligrams[mg] twice daily) or placebo for 9 months in the double-blind phase. After 9 months, patients have the option to continue in the open-label phase and receive treatment with topiramate for 1 year. Patients in the placebo group then receive topiramate with dosage increasing gradually to 96 mg twice daily, with the option of increasing to 256 mg twice daily. Patients in the topiramate group continue with the maintenance dose received during the double-blind phase, with the option of increasing to 256 mg twice daily. Assessments of effectiveness made monthly include insulin sensitivity, body composition (as measured by computed tomography [CT]), body weight and Body Mass Index (BMI), waist and hip circumferences, fasting lipid profile, fasting glucose and hemoglobin type A1c (HbA1c) levels, and blood pressure. Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms [ECGs]), are performed throughout the study. The study hypothesis is that topiramate will improve insulin sensitivity in type 2 diabetic patients and will be well tolerated. Patients will be randomized to receive 192 mg/day (96mg twice daily) of topiramate, or placebo, per mouth for 9 months, with an option of topiramate treatment increasing to 256mg/day both groups during the extension period of 1 year.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a history of Type 2 diabetes for 6 months, treated either by diet alone or by sulfonylurea for at least 6 months
  • Hemoglobin A1c between 6.5% and 10%
  • BMI between 27 and 50
  • Non-smokers
  • Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception

Exclusion Criteria:

  • Unstable endocrine disease
  • Significantly abnormal liver function or kidney functions
  • History of schizophrenia, major depressive disorder or eating disorder
  • History of epilepsy, kidney stones or substance (alcohol) abuse
  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: NCT00236626

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: NCT00236626     History of Changes
Other Study ID Numbers: CR003715
Study First Received: October 7, 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
Insulin Resistance
Body Mass Index
Hypertension
Hyperlipidemia
Sulfonylurea
Topiramate
Adult-Onset Diabetes Mellitus
Metabolic Syndrome

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
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 September 22, 2014