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

Completed

• Conditions: Obesity; Diabetes Mellitus Type 2
• Interventions: Other: No intervention

• Registration Number: NCT00304603
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief 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.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2006-03-17
• Study First Submitted QC: 2006-03-17
• Study First Posted: 2006-03-20
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1145

Inclusion Criteria

• Must have been randomized within the previous topiramate obesity and diabetes studies: PRI/TOP-INT-31 or PRI/TOP-INT-33 or a subset of patients with diabetes mellitus who were randomized within the PRI/TOP-INT-34 study at sites that also participated in the PRI/TOP-INT-31 study
• Must consent to participate and use data from previous clinical trials in connection with results from the genetic analyses

Exclusion Criteria

• Patients who received a blood transfusion within 60 days before collecting DNA samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients from previous topiramate obesity and diabetes studies	No intervention	The patients from previous topiramate obesity and diabetes studies (PRI/TOP-INT-31 or PRI/TOP-INT-33 or a subset of patients with diabetes mellitus who were randomized within the PRI/TOP-INT-34 study at sites that also participated in the PRI/TOP-INT-31 study.

Primary Outcome Measures

Name	Time	Method
Percent change in weight	Baseleine to Week 24	The candidate gene analyses and the genome (entire hereditary information of organism) screen for percent change in weight will be performed in 3 phases. 1) Find polymorphisms (existence of distinctly different types in group of 1 species) within candidate genes and chromosomal regions that impact response to topiramate. 2) Confirm Phase 1 findings. 3) Verify that polymorphisms and chromosomal regions that were associated with percent change in weight in 2 phases are associated with percent change in weight in response to topiramate rather than change in diet and exercise.

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	Baseline to Week 24
Change in in glycosylated hemoglobin (HbA1c)	Baseline to Week 24
Number of patients with central nervous system (CNS) related adverse events	Baseline to Week 24	Most frequent CNS-related adverse events (ie, paresthesia, depression, difficulty with concentration/attention, anorexia, difficulty with memory, fatigue, somnolence, insomnia, mood problems, and hypoesthesia) and adverse events related to venipuncture are monitored during the study.