NCT00231634

Brief Summary

The purpose of this study is to compare the effectiveness and safety of topiramate with placebo in the treatment of obesity and Type 2 diabetes mellitus in patients who have failed on sulfonylurea therapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started May 2001

Shorter than P25 for phase_3 obesity

Status
terminated

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

May 1, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

June 8, 2011

Status Verified

January 1, 2011

First QC Date

September 30, 2005

Last Update Submit

June 6, 2011

Conditions

ObesityDiabetes Mellitus, Type 2Diabetes Mellitus, Adult-Onset

Keywords

ObesityType 2 Diabetes MellitusHbA1cSulfonylureaTopiramateAdult-Onset Diabetes Mellitus (AODM)

Outcome Measures

Primary Outcomes (1)

  • Percent change in body weight and change in Hemoglobin A1c (HbA1c) from baseline to Week 52.

Secondary Outcomes (1)

  • Change from baseline to Week 52 in BMI, FPG; safety evaluations (adverse events, hypoglycemic events) throughout study.

Interventions

topiramateDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Type 2 Diabetes, receiving only second generation sulfonylurea therapy (may include: glipizide, gliclazide, glimepiride, glibenclamide/glyburide, and gliquadone) for at least 4 months and on stable dose for at least 2 months
  • Body Mass Index \>= 27 and \< 50
  • HbA1c \< 11% at enrollment
  • Diagnosed hypertension or hyperlipidemia must be controlled
  • Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)

You may not qualify if:

  • Known contraindication or hypersensitivity to topiramate or sulfonylurea therapy
  • Pregnancy or women who are nursing or plan to become pregnant during the study
  • Diagnosed with Type 1 diabetes
  • History of severe or recurrent hypoglycemic episodes
  • Treatment with any antidiabetic agent other than sulfonylurea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

Topiramate

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

May 1, 2001

Study Completion

November 1, 2002

Last Updated

June 8, 2011

Record last verified: 2011-01