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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Diabetes Mellitus Type 2; Obesity

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00304603

RWJ-17021-000 (Other Identifier)

CR003409

TOPMAT-OBE-3001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,145 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,145 participants in 1 patient group

Patients from previous topiramate obesity and diabetes studies

Description:

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.

Treatment:

Other: No intervention