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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00304603
First received: March 17, 2006
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Diabetes Mellitus Type 2
Other: No intervention
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Percent change in weight [ Time Frame: Baseleine to Week 24 ] [ Designated as safety issue: No ]
    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:
  • Change in in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Number of patients with central nervous system (CNS) related adverse events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
    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.

  • Number of patients with adverse events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 1145
Study Start Date: April 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients from previous topiramate obesity and diabetes studies
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.
Other: No intervention
No treatment was given to the patients as this is an observational study.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304603

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00304603     History of Changes
Other Study ID Numbers: CR003409, TOPMAT-OBE-3001, RWJ-17021-000
Study First Received: March 17, 2006
Last Updated: November 27, 2012
Health Authority: United States: None due to the nature of study

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Obesity
Type 2 Diabetes Mellitus
Topiramate
Pharmacogenomics
DNA Polymorphism

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 20, 2014