Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231634
Status:
TERMINATED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Brief Title:
A Study of the Efficacy and Safety of Topiramate in Obese Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy
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 Inadequately Controlled on Sulfonylurea Therapy
Status:
TERMINATED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Program discontinued
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 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
Detailed Description:
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 episodes 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 milligramsmg 192mg or 256mg daily the dose will be maintained for 44 weeks
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