NCT00236626

Brief Summary

The purpose of this study is to investigate (1) the effect of topiramate on insulin sensitivity in overweight or obese patients with type 2 diabetes mellitus and (2) the safety of topiramate in type 2 diabetic patients. The study will also investigate the effect of topiramate on body weight, body fat, fat distribution, and metabolic control including both glucose and lipid levels.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Apr 2000

Typical duration for phase_2 obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

June 8, 2011

Status Verified

April 1, 2010

First QC Date

October 7, 2005

Last Update Submit

June 6, 2011

Conditions

ObesityDiabetes Mellitus, Type 2Diabetes Mellitus, Adult-Onset

Keywords

Type 2 DiabetesObesityInsulin ResistanceBody Mass IndexHypertensionHyperlipidemiaSulfonylureaTopiramateAdult-Onset Diabetes MellitusMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Mean change in insulin sensitivity from baseline to Month 9.

Secondary Outcomes (1)

  • Mean change, baseline to Month 9, in body weight and composition, Body Mass Index (BMI), lipid profile, fasting glucose; blood pressure; safety evaluations (adverse events) during study.

Interventions

topiramateDRUG

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a history of Type 2 diabetes for 6 months, treated either by diet alone or by sulfonylurea for at least 6 months
  • Hemoglobin A1c between 6.5% and 10%
  • BMI between 27 and 50
  • Non-smokers
  • Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception

You may not qualify if:

  • Unstable endocrine disease
  • Significantly abnormal liver function or kidney functions
  • History of schizophrenia, major depressive disorder or eating disorder
  • History of epilepsy, kidney stones or substance (alcohol) abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin ResistanceHypertensionHyperlipidemiasMetabolic Syndrome

Interventions

Topiramate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinismVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

April 1, 2000

Study Completion

May 1, 2002

Last Updated

June 8, 2011

Record last verified: 2010-04