Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231660
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Brief Title:
A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese Type 2 Diabetic Patients Treated With Metformin
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 of the Efficacy and Safety of Topiramate in the Treatment of Obese Type 2 Diabetic Patients Treated With Metformin
Status:
COMPLETED
Status Verified Date:
2011-01
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 compare the efficacy in terms of weight and hemoglobin type A1c HbA1c and safety of topiramate 96 milligramsmg or 192 mg daily with placebo in the treatment of obesity in Type 2 diabetic patients receiving metformin
Detailed Description:
Topiramate is not approved for the treatment of obesity This double-blind placebo-controlled study is designed to assess the efficacy and safety of topiramate in Type 2 diabetic patients with obesity who are well-controlled on metformin alone Patients are randomized to receive either topiramate up to a target dose of 96 or 192 mg per day or placebo for one year Assessments of efficacy include weight reduction levels of HbA1c shows average blood sugar level over a few months Body Mass Index BMI and Health Related Quality of Life HRQOL measures Safety evaluations incidence of adverse events vital signs hypoglycemic events electrocardiograms ECGs clinical laboratory values are monitored throughout the study The study hypothesis is that topiramate combined with metformin and non-pharmacologic therapy can effectively achieve significant weight reduction and is well tolerated During the first 8 weeks oral doses of matching placebo or topiramate are increased gradually to target dose 96 milligramsmg or 192mg daily the dose will be maintained for 1 year then gradually reduced and stopped
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