A Study Using DNA Samples From Patients Who Participated in Previous Topiramate Obesity and Type 2 Diabetes Studies

Condition(s) targeted: Obesity; Diabetes Mellitus, Type 2

Status: No longer recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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 and the clinical outcomes.

Official title: 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

Study design: Observational, Screening, Cross-Sectional, Defined Population, Retrospective Study

Detailed description: Previous studies suggest that genetic factors may play a significant role in determining the amount of weight loss in response to pharmacological treatment. Topiramate is not approved for the treatment of obesity, but reported weight changes in response to treatment with topiramate may be linked to genetic factors. This pharmacogenomics (effect of genetic variation on drug response) study will analyze genetic variations in the DNA extracted from blood samples collected from subjects who were randomized 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 (10ml of whole blood) for genetic analyses, and a 24-hour post-sample adverse event-reporting period. The goal of the study is to identify genes that impact percent change in weight and HbA1c from baseline at Week 24 (of the selected studies) and the occurrence of the most frequent central nervous system (CNS)-related adverse events in response to topiramate. The study hypothesis is that there are certain types of genes that are involved in the mode of action of topiramate.

No study drug was administered.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient must have been randomized within the select previous topiramate obesity and diabetes studies: CR003721 or CR003712 or a subset of subjects with diabetes mellitus who were randomized within the CR003718 study at sites that also participated in the CR003721

Exclusion Criteria:

- Patient must have been randomized within the select previous topiramate obesity and diabetes studies: CR003721 or CR003712 or a subset of subjects with diabetes mellitus who were randomized within the CR003718 study at sites that also participated in the CR003721

Starting date: April 2004
Ending date: April 2005
Last updated: March 17, 2006