Clinical trial NCT00304603: Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes Mellitus Type 2
Keywords: Obesity
Type 2 Diabetes Mellitus
Topiramate
Pharmacogenomics
DNA Polymorphism
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2006-03-20
Enrollment: 1145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent change in weight
timeFrame: Baseleine to Week 24
Secondary outcomes:
measure: Change in in glycosylated hemoglobin (HbA1c)
timeFrame: Baseline to Week 24
measure: Number of patients with central nervous system (CNS) related adverse events
timeFrame: Baseline to Week 24
measure: Number of patients with adverse events
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: