NCT00304603

Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus

A Study to Evaluate the Mode of Action of Topiramate in the Treatment of Obese Subjects With and Without Type 2 Diabetes Mellitus Using DNA Samples From Subjects Who Were Randomized Within Select Previous Topiramate Studies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,145 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the mode of action of topiramate in the treatment of obese and diabetic patients by testing association between genetic variations within candidate genes or chromosomes (thread like structure found in cell which carries genes) and the clinical outcomes.

Detailed description

This pharmacogenomics (effect of genetic variation on drug response) study will analyze genetic variations in the DNA extracted from blood samples collected from patients who were randomized (assigned to treatments by chance) in 1 of 3 previous topiramate studies on obesity and diabetes. The study consist of a screening telephone contact, a single visit to the study site for a blood sample collection (10 ml of whole blood) for genetic analyses, and a 24-hour post-sample adverse event reporting period. The total duration of the study is 24 hours from the time of the blood sample collection. Safety will be monitored up to 24 hours after blood sample collection. No study medication was administered.

Conditions

• Obesity
• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
OTHER	No intervention	No treatment was given to the patients as this is an observational study.

Timeline

• Start date: 2004-04-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2006-03-20
• Last updated: 2012-11-28