Prediabetic StatePhase 3RAPSODINCT00325650
Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
A Phase 3 study testing Rimonabant in people with Prediabetic State, run by Sanofi at 1 site in United States.
Trial summary
Primary objective: To evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or both at baseline). Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Rimonabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,420 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Mar 2009
- Phase
- Phase 3
- 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
- No previous history of treatment for type 2 diabetes.
- Diagnosis of :
- Impaired Glucose Tolerance (IGT) based on one oral glucose tolerance test (OGTT) and defined as a 2 hour post-challenge glucose (after a 75-g Oral Glucose Tolerance Test) > 140 mg/dL (7.8 mmol/L) but < 200 mg/dL (11.1 mmol/L), at the screening visit.
- And / or impaired fasting glucose (IFG) based on a Fasting Plasma Glucose (FPG) ³ 100 mg/dL (5.6 mmol/L) and < 126 mg/dL (7.0 mmol/L), at the screening visit.
Who cannot join
- Absence of effective contraceptive method for females of childbearing potential.
- Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit.
- Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
- Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
- Related to laboratory findings:
- positive test for hepatitis B surface antigen and/or hepatitis C antibody;
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- Positive urine pregnancy test in females of childbearing potential ;
- Thyroid-stimulating hormone (TSH) and free T4 outside central laboratory normal range.
- Related to previous or concomitant medications:
- Within 3 months prior to screening visit and/or during the screening period:
- anti-obesity drugs (e.g., sibutramine, orlistat, herbal preparations, etc),
- systemic long-acting corticosteroids; prolonged use (more than 10 days) of systemic corticosteroids;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Long-term Administration of Rimonabant in the Prevention of Type 2 Diabetes in Patients With Prediabetic Status (i.e., Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Both)
Primary objective:
To evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or both at baseline).
Secondary objectives:
- To assess the effect on weight loss and weight maintenance; sustained effect following a washout period, effect on other markers of glycemic control (fasting glucose, fasting-insulin and HbA1c), glucose tolerance and insulin responses during oral glucose tolerance tests (OGTTs), and on other risk factors (HDL-Cholesterol, TG),
- To assess the effect on quality of life
- To evaluate long term safety and tolerability.
Read the detailed description
The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.
- Conditions
- Prediabetic State
- Being tested
- Rimonabant, Placebo (for Rimonabant)
- Keywords
- Prediabetic state, Impaired fasting glucose, Impaired glucose Tolerance
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Also called SR141716, Acomplia
Tablet, oral administration
Placebo (for Rimonabant)Drug
Tablet, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Experimental | Rimonabant 20 mg once daily Receives: Drug: Rimonabant |
| Placebo | Placebo comparator | Placebo (for Rimonabant) once daily. Receives: Drug: Placebo (for Rimonabant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of progression to type 2 diabetes
Measured: Baseline to 30 months
Secondary outcomes (5)
Change from baseline in body weight
Measured: Baseline to 30 months
Change from baseline in waist circumference
Measured: Baseline to 30 months
Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin)
Measured: Baseline to 30 months
Change from baseline in glucose and insulin at 2 hour post-glucose load
Measured: Baseline to 30 months
Change from baseline in HDL-Cholesterol and triglycerides (TG)
Measured: Baseline to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Company decision taken in light of demands by certain national health authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325650
- Sponsor's protocol ID
- EFC5107
- Acronym
- RAPSODI
- Status last verified
- Apr 2016
- First submitted
- 12 May 2006
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Long-term Administration of Rimonabant in the Prevention of Type 2 Diabetes in Patients With Prediabetic Status (i.e., Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Both)
- ClinicalTrials.gov ID
- NCT00325650
- Acronym / sponsor ID
- RAPSODI / EFC5107
- Conditions
- Prediabetic State
- Keywords
- Prediabetic state, Impaired fasting glucose, Impaired glucose Tolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 2,420 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 May 2006 (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.
Primary objective:
To evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes (i.e. Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or both at baseline).
Secondary objectives:
- To assess the effect on weight loss and weight maintenance; sustained effect following a washout period, effect on other markers of glycemic control (fasting glucose, fasting-insulin and HbA1c), glucose tolerance and insulin responses during oral glucose tolerance tests (OGTTs), and on other risk factors (HDL-Cholesterol, TG),
- To assess the effect on quality of life
- To evaluate long term safety and tolerability.
Detailed description
The total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimonabant | Experimental | Drug: RimonabantRimonabant 20 mg once daily |
| Placebo | Placebo comparator | Drug: Placebo (for Rimonabant)Placebo (for Rimonabant) once daily. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No previous history of treatment for type 2 diabetes.
- Diagnosis of :
Key exclusion criteria (12 listed)
- Absence of effective contraceptive method for females of childbearing potential.
- Presence of any clinically significant endocrine disease according to the Investigator.Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit.
- Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
- Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
- Related to laboratory findings:
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 |
|---|---|---|
| RimonabantAlso: SR141716, AcompliaTablet, oral administration | Drug | Rimonabant |
| Placebo (for Rimonabant)Tablet, oral administration | Drug | Placebo |
Primary outcome
Time of progression to type 2 diabetes
Time frame: Baseline to 30 months
5 secondary outcomes
Change from baseline in body weight
Time frame: Baseline to 30 months
Change from baseline in waist circumference
Time frame: Baseline to 30 months
Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin)
Time frame: Baseline to 30 months
Change from baseline in glucose and insulin at 2 hour post-glucose load
Time frame: Baseline to 30 months
Change from baseline in HDL-Cholesterol and triglycerides (TG)
Time frame: Baseline to 30 months
Results and safety
The study was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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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.
ICD CSD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant in people with Prediabetic State, run by Sanofi at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
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?
Time of progression to type 2 diabetes (time frame: Baseline to 30 months). 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 18 May 2016.