ObesityPhase 2NCT00236626
A Study of the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Patients With Type 2 Diabetes
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 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. Read more about this study
- Who is it for?
- Ages 35 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
- 38 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to May 2002
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A 9 Month, Double-Blind, Placebo-Controlled Study With a Blinded Crossover Transition to Open-Label Extension, Evaluating the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Type 2 Diabetes Patients
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.
Read the detailed description
Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study investigates the effect of topiramate on insulin sensitivity in overweight or obese patients with Type 2 Diabetes. After a screening phase, patients are randomized to receive either topiramate (96 milligrams[mg] twice daily) or placebo for 9 months in the double-blind phase. After 9 months, patients have the option to continue in the open-label phase and receive treatment with topiramate for 1 year. Patients in the placebo group then receive topiramate with dosage increasing gradually to 96 mg twice daily, with the option of increasing to 256 mg twice daily. Patients in the topiramate group continue with the maintenance dose received during the double-blind phase, with the option of increasing to 256 mg twice daily. Assessments of effectiveness made monthly include insulin sensitivity, body composition (as measured by computed tomography [CT]), body weight and Body Mass Index (BMI), waist and hip circumferences, fasting lipid profile, fasting glucose and hemoglobin type A1c (HbA1c) levels, and blood pressure. Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms [ECGs]), are performed throughout the study. The study hypothesis is that topiramate will improve insulin sensitivity in type 2 diabetic patients and will be well tolerated. Patients will be randomized to receive 192 mg/day (96mg twice daily) of topiramate, or placebo, per mouth for 9 months, with an option of topiramate treatment increasing to 256mg/day both groups during the extension period of 1 year.
- Being tested
- topiramate
- Keywords
- Type 2 Diabetes, Obesity, Insulin Resistance, Body Mass Index, Hypertension, Hyperlipidemia, Sulfonylurea, Topiramate, Adult-Onset Diabetes Mellitus, Metabolic Syndrome
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance, Hypertension, Hyperlipidemias, Metabolic Syndrome
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startApr 2000
- Study completionMay 2002
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
- 38 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
- NCT00236626
- Sponsor's protocol ID
- CR003715
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 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 9 Month, Double-Blind, Placebo-Controlled Study With a Blinded Crossover Transition to Open-Label Extension, Evaluating the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT00236626
- Acronym / sponsor ID
- CR003715
- Keywords
- Type 2 Diabetes, Obesity, Insulin Resistance, Body Mass Index, Hypertension, Hyperlipidemia, Sulfonylurea, Topiramate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2000
- Study completion
- May 2002 (actual)
- First posted
- 12 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 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.
Detailed description
Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study investigates the effect of topiramate on insulin sensitivity in overweight or obese patients with Type 2 Diabetes. After a screening phase, patients are randomized to receive either topiramate (96 milligrams[mg] twice daily) or placebo for 9 months in the double-blind phase. After 9 months, patients have the option to continue in the open-label phase and receive treatment with topiramate for 1 year. Patients in the placebo group then receive topiramate with dosage increasing gradually to 96 mg twice daily, with the option of increasing to 256 mg twice daily. Patients in the topiramate group continue with the maintenance dose received during the double-blind phase, with the option of increasing to 256 mg twice daily. Assessments of effectiveness made monthly include insulin sensitivity, body composition (as measured by computed tomography [CT]), body weight and Body Mass Index (BMI), waist and hip circumferences, fasting lipid profile, fasting glucose and hemoglobin type A1c (HbA1c) levels, and blood pressure. Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms [ECGs]), are performed throughout the study. The study hypothesis is that topiramate will improve insulin sensitivity in type 2 diabetic patients and will be well tolerated. Patients will be randomized to receive 192 mg/day (96mg twice daily) of topiramate, or placebo, per mouth for 9 months, with an option of topiramate treatment increasing to 256mg/day both groups during the extension period of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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
Mean change in insulin sensitivity from baseline to Month 9.
1 secondary outcome
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.
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 of the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Patients with Type 2 DiabetesLink 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 5 inclusion and 4 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?
Mean change in insulin sensitivity from baseline to Month 9.. 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.