A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet

NCT00231530 | Completed Phase 3

• 1 other identifier: CR003712
• Study Type: interventional
• Target: 541
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the efficacy and safety of topiramate compared with placebo in obese, Type 2 diabetic patients on a controlled diet.

Conditions

Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset

Keywords

Type 2 Diabetes Mellitus; Obesity; Diabetic Diet; Hypertension; Hyperlipidemia; Adult-Onset Diabetes Mellitus(AODM)

Outcome Measures

Primary Outcomes (1)

• The percent change in body weight and change in Hemoglobin A1c from enrollment to Week 60.

Secondary Outcomes (1)

• Change from enrollment or baseline to Week 60 in BMI, waist circumference, glucose tolerance, lipid profile; safety measures, such as adverse events, throughout study.

Interventions

topiramate DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index \>= 27 and \< 50
• Diagnosis of Type 2 diabetes according to either Swedish guideline or the American Diabetes Association (ADA) criteria
• HbA1c \<10.5% at enrollment
• No previous oral antidiabetic medication or insulin therapy
• Stable body weight
• Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)

You may not qualify if:

• Known contraindication or hypersensitivity to topiramate
• Fasting plasma glucose (FPG) \>= 13.1 millimolesl/liter (240 milligrams/deciliter) at baseline, Visit 4 (Week 0)
• HBA1c of \>10.5% at enrollment
• History of severe recurrent hypoglycemic episodes prior to study entry
• Use of any systemic corticosteroids within 30 days of enrollment
• Diagnosed Type 1 diabetes
• History of significant cardiovascular disease, uncontrolled thyroid disease, or kidney stones

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Hypertension; Hyperlipidemias

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: January 1, 2001
• Study Completion: May 1, 2002
• Last Updated: June 8, 2011

Record last verified: 2010-04