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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 )
Study NCT00231634   Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First Received: September 30, 2005   Last Updated: May 16, 2008   History of Changes

September 30, 2005
May 16, 2008
 
 
Pecent change in body weight and change in Hemoglobin A1c (HbA1c) from baseline to Week 52.
Same as current
Complete list of historical versions of study NCT00231634 on ClinicalTrials.gov Archive Site
Change from baseline to Week 52 in BMI, FPG; safety evaluations (adverse events, hypoglycermic events) throughout study.
Same as current
 
A Study of the Efficacy and Safety of Topiramate in Obese, Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy
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.

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 epidoses, 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.

Phase III
Interventional
Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment
  • Diabetes Mellitus, Adult-Onset
  • Diabetes Mellitus, Type 2
  • Obesity
Drug: topiramate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
580
June 2002
 

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00231634
 
CR002251
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
May 2008

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