Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231530
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Brief Title:
A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese Type 2 Diabetes Patients on a Controlled Diet
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Obese Type 2 Diabetic Patients on a Controlled Diet
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 determine the efficacy and safety of topiramate compared with placebo in obese Type 2 diabetic patients on a controlled diet
Detailed Description:
Topiramate is not approved for the treatment of obesity This is a randomized double-blind placebo-controlled study to evaluate the efficacy and safety of topiramate in obese diet-controlled type 2 diabetic patients Patients are randomized to receive either topiramate or placebo After a 5 week pre-enrollment phase followed by a 6 week run-in phase patients in the topiramate group start an 8-week titration phase to reach the assigned dose of topiramate either 96 or 192 mg daily Treatment continues for 1 year Assessments of effectiveness include percent change in body weight hemoglobin type A1c HbA1c levels Body Mass Index BMI the numbers and proportion of 5 and 10 weight loss responders glucose tolerance waist and hip circumferences changes in the mass of left ventricle of the heart blood pressures and fasting lipid profiles Safety evaluations including incidence of adverse events vital signs clinical laboratory values and electrocardiograms ECGs are monitored throughout the study The study hypothesis is that topiramate combined with controlled diet will be effective in weight reduction and controlling blood sugar level and is well tolerated During the initial 8 weeks the oral doses of either a matching placebo or topiramate will be gradually increased to the target doses 96 milligramsmg or 192mg daily the dose will be maintained for 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