Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236626
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-07
Brief Title:
A Study of the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Patients With Type 2 Diabetes
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 milligramsmg 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 mgday 96mg twice daily of topiramate or placebo per mouth for 9 months with an option of topiramate treatment increasing to 256mgday both groups during the extension period of 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None