ObesityPhase 3SOLONCT00478972
Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise
A Phase 3 study testing Rimonabant and Diet and exercise in people with Obesity and Diabetes Mellitus Type 2, run by Sanofi at 1 site in Japan.
Trial summary
The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obesity, Diabetes Mellitus Type 2
- What is being tested?
- Rimonabant and Diet and exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2007to Jan 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
- HbA1C ≥ 7.0 % and ≤ 10.0 %
- Body Mass Index ≥ 25 kg/m²
Who cannot join
- Type 1 diabetes
- Within 12 weeks prior to screening visit: use of oral antidiabetic drugs and/or insulin, of anti-obesity drugs or other drugs for weight reduction
- Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
- Secondary obesity
- Primary hyperlipidemia
- Positive serum pregnancy test in females of childbearing potential
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients Inadequately Controlled With Diet and Exercise Alone
The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.
The secondary objectives are:
- To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
- To evaluate the safety and tolerability of Rimonabant compared to placebo;
- To evaluate the pharmacokinetics of Rimonabant.
Read the detailed description
The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.
- Conditions
- Obesity, Diabetes Mellitus Type 2
- Being tested
- Rimonabant, placebo (for Rimonabant), Diet and exercise
- Keywords
- obese, diabetes, cannabinoid-1 receptor
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus
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
Diet and exerciseOther
Target daily caloric intake: Ideal body weight × 25 kcal
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Experimental | Rimonabant 20 mg once daily in addition to diet and exercise Receives: Drug: Rimonabant; Other: Diet and exercise |
| Placebo | Placebo comparator | Placebo (for Rimonabant) once daily in addition to diet and exercise Receives: Drug: placebo (for Rimonabant); Other: Diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in HbA1C
Measured: Baseline to Week 36
Relative change from baseline in body weight
Measured: Baseline to Week 36
Secondary outcomes (4)
Absolute change from baseline in Fasting Plasma Glucose
Measured: Baseline to Week 36
Absolute change from baseline in waist circumference
Measured: Baseline to Week 36
Relative change from baseline in Triglycerides and HDL-cholesterol
Measured: Baseline to Week 36
Safety: Overview of adverse events
Measured: Baseline to Week 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2009
- Study completionJan 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 ObesityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 321 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
- NCT00478972
- Sponsor's protocol ID
- EFC6648
- Acronym
- SOLO
- Status last verified
- Jun 2016
- First submitted
- 24 May 2007
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen, Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients Inadequately Controlled With Diet and Exercise Alone
- ClinicalTrials.gov ID
- NCT00478972
- Acronym / sponsor ID
- SOLO / EFC6648
- Conditions
- Obesity, Diabetes Mellitus Type 2
- Keywords
- obese, diabetes, cannabinoid-1 receptor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 321 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 May 2007 (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 primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone.
The secondary objectives are:
- To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
- To evaluate the safety and tolerability of Rimonabant compared to placebo;
- To evaluate the pharmacokinetics of Rimonabant.
Detailed description
The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimonabant | Experimental | Drug: Rimonabant, Other: Diet and exerciseRimonabant 20 mg once daily in addition to diet and exercise |
| Placebo | Placebo comparator | Drug: placebo (for Rimonabant), Other: Diet and exercisePlacebo (for Rimonabant) once daily in addition to diet and exercise |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 Diabetes Mellitus patients inadequately treated with diet and exercise alone (not drug treated)
- HbA1C ≥ 7.0 % and ≤ 10.0 %
- Body Mass Index ≥ 25 kg/m²
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Within 12 weeks prior to screening visit: use of oral antidiabetic drugs and/or insulin, of anti-obesity drugs or other drugs for weight reduction
- Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
- Secondary obesity
- Primary hyperlipidemia
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 |
| Diet and exerciseTarget daily caloric intake: Ideal body weight × 25 kcal | Other | Placebo, Rimonabant |
Primary outcome
Absolute change from baseline in HbA1C
Time frame: Baseline to Week 36
Relative change from baseline in body weight
Time frame: Baseline to Week 36
4 secondary outcomes
Absolute change from baseline in Fasting Plasma Glucose
Time frame: Baseline to Week 36
Absolute change from baseline in waist circumference
Time frame: Baseline to Week 36
Relative change from baseline in Triglycerides and HDL-cholesterol
Time frame: Baseline to Week 36
Safety: Overview of adverse events
Time frame: Baseline to Week 47
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 8 Jun 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 and Diet and exercise in people with Obesity and Diabetes Mellitus Type 2, run by Sanofi at 1 site in Japan.
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 3 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: stopped early, as of the sponsor's last update on 8 Jun 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 Japan. 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?
Absolute change from baseline in HbA1C (time frame: Baseline to Week 36). The study lists 2 primary outcomes in all. 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 2016.