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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304603
• Other study ID #: CR003409
• Secondary ID: TOPMAT-OBE-3001R
• Status: Completed
• Phase: Phase 3
• First received: March 17, 2006
• Last updated: November 27, 2012
• Start date: April 2004
• Est. completion date: April 2005

Study information

• Verified date: November 2012
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: None due to the nature of study
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1145
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Other:
• No intervention
No treatment was given to the patients as this is an observational study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in weight	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.	Baseleine to Week 24	No
Secondary	Change in in glycosylated hemoglobin (HbA1c)		Baseline to Week 24	No
Secondary	Number of patients with central nervous system (CNS) related adverse events	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.	Baseline to Week 24	Yes
Secondary	Number of patients with adverse events		Baseline to Week 24	Yes

External Links

•   A Study to Explore 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 Obesity and Diabetes Studies