ObesityPhase 2NCT00231647
A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
A Phase 2 study testing topiramate in people with Obesity and Diabetes Mellitus, Type 2, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset
- What is being tested?
- topiramate
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Oct 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) >= 27 kg/m^2 and <50 kg/m^2
- Diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin
- Stable weight for at least 2 months
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test).
Who cannot join
- Contraindication or hypersensitivity to topiramate
- Exposure to any other experimental drug or device within past 90 days
- Established diagnosis of Type 1 diabetes
- History of severe or recurrent hypoglycemic episodes prior to study entry
- Taking oral antidiabetic medications other than metformin
- Treatment with insulin within 4 months
- Significant liver, kidney or cardiovascular diseases.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Assess the Efficacy and Safety of Topiramate OROS Controlled-Release in the Treatment of Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
The purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin.
Read the detailed description
Topiramate is not approved for the treatment of obesity. Studies have shown that an immediate release formulation of topiramate reduces body weight in obese patients with or without type 2 diabetes. A novel controlled-release formulation of topiramate using OROS® technology has the potential for better efficacy and safety in the treatment of obesity. This double-blind, placebo controlled study will evaluate the effectiveness and safety of the controlled-release formulation in the treatment of obese subjects with type 2 diabetes. The study consists of 2 screening visits, a baseline visit, 7-week titration phase (topiramate dose will be increased from 25mg daily to 175mg daily), 9-week maintenance phase, 2-week taper phase and a 2-week follow-up. Effectiveness will be evaluated by the percent change in body weight, body mass index, and anthropometric measurements (waist and hip circumferences and their ratio). Safety evaluations (incidence and severity of adverse events, physical measurements and clinical laboratory tests) will be conducted throughout the study. The study hypothesis is that topiramate 175 mg daily, when administered as the OROS® controlled-release formulation, is effective (in terms of percent reduction in body weight from baseline to week 16) and safe, as compared with placebo, in the treatment of obese, type 2 diabetic patients managed with either diet alone or combined with metformin. During the titration phase, topiramate (in the OROS® controlled-release formulation) will be gradually increased to 175mg daily by mouth, and the dose will be maintained for 9 weeks, and then slowly discontinued over 2 weeks.
- Being tested
- topiramate
- Keywords
- Obesity, Type 2 Diabetes Mellitus, Metformin, Diabetic Diet, Topiramate, Adult-Onset Diabetes Mellitus (AODM)
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline to Week 16.
Secondary outcomes (1)
Changes in body weight, body mass index,anthropometric measurements (waste and hip circumference and their ratio),fasting blood glucose and lipid profile from baseline to Week 16; safety evaluations including incidence of adverse events during the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startFeb 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231647
- Sponsor's protocol ID
- CR002674
- Status last verified
- Jan 2011
- First submitted
- 30 Sep 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Assess the Efficacy and Safety of Topiramate OROS Controlled-Release in the Treatment of Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin
- ClinicalTrials.gov ID
- NCT00231647
- Acronym / sponsor ID
- CR002674
- Keywords
- Obesity, Type 2 Diabetes Mellitus, Metformin, Diabetic Diet, Topiramate, Adult-Onset Diabetes Mellitus (AODM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Oct 2004 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin.
Detailed description
Topiramate is not approved for the treatment of obesity. Studies have shown that an immediate release formulation of topiramate reduces body weight in obese patients with or without type 2 diabetes. A novel controlled-release formulation of topiramate using OROS® technology has the potential for better efficacy and safety in the treatment of obesity. This double-blind, placebo controlled study will evaluate the effectiveness and safety of the controlled-release formulation in the treatment of obese subjects with type 2 diabetes. The study consists of 2 screening visits, a baseline visit, 7-week titration phase (topiramate dose will be increased from 25mg daily to 175mg daily), 9-week maintenance phase, 2-week taper phase and a 2-week follow-up. Effectiveness will be evaluated by the percent change in body weight, body mass index, and anthropometric measurements (waist and hip circumferences and their ratio). Safety evaluations (incidence and severity of adverse events, physical measurements and clinical laboratory tests) will be conducted throughout the study. The study hypothesis is that topiramate 175 mg daily, when administered as the OROS® controlled-release formulation, is effective (in terms of percent reduction in body weight from baseline to week 16) and safe, as compared with placebo, in the treatment of obese, type 2 diabetic patients managed with either diet alone or combined with metformin. During the titration phase, topiramate (in the OROS® controlled-release formulation) will be gradually increased to 175mg daily by mouth, and the dose will be maintained for 9 weeks, and then slowly discontinued over 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) >= 27 kg/m^2 and <50 kg/m^2
- Diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin
- Stable weight for at least 2 months
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test).
Key exclusion criteria (7 listed)
- Contraindication or hypersensitivity to topiramate
- Exposure to any other experimental drug or device within past 90 days
- Established diagnosis of Type 1 diabetes
- History of severe or recurrent hypoglycemic episodes prior to study entry
- Taking oral antidiabetic medications other than metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topiramate | Drug | – |
Primary outcome
Percent change in body weight from baseline to Week 16.
1 secondary outcome
Changes in body weight, body mass index,anthropometric measurements (waste and hip circumference and their ratio),fasting blood glucose and lipid profile from baseline to Week 16; safety evaluations including incidence of adverse events during the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- A Study on Efficacy and Safety of Topiramate OROS� Controlled-Release in Obese Type 2, Diabetic Subjects Managed with Diet or MetforminLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing topiramate in people with Obesity and Diabetes Mellitus, Type 2, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight from baseline to Week 16.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.