Type 2 Diabetes MellitusPhase 3SERENADENCT00257257
Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients
A Phase 3 study testing Rimonabant (SR141716) in people with Type 2 Diabetes Mellitus, run by Sanofi at 7 sites in 7 countries.
Trial summary
Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight, HDL-cholesterol, triglycerides, blood pressure - Safety, tolerability Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Rimonabant (SR141716)
- How many people
- 281 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Mar 2005to Jun 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged greater than or equal to 18 years.
- Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months but no longer than 3 years.
- Type 2 diabetes not previously treated by a pharmacological agent.
- Note:
- a) insulin use is accepted if it is not within 6 months prior to screening visit and only for the following reasons:
- prior use for management of gestational diabetes,
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- short-term (less than or equal to 1 month) use to maintain glycemic control for hospitalization, medical procedures, or intervention.
- b) use of an oral antidiabetic agent is accepted if it is not within 6 months prior to screening visit and only if it was prescribed for no more than 4 months.
- HbA1C greater than or equal to 7% and less than or equal to 10%.
- Having signed the informed consent form.
Who cannot join
- General:
- Weight loss > 5 kg within 3 months prior to screening visit.
- Pregnancy or lactation.
- Absence of medically approved contraceptive methods for females of childbearing potential.
- Marijuana or hashish users.
- Administration of other investigational drugs within 30 days prior to screening visit.
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- Previous participation in a rimonabant study.
- Presence or history of allergic reaction or intolerance to multiple drugs.
- Presence of any other condition (e.g., geographic, social) that the Investigator feels that would restrict or limit the patient's participation for the duration of the study.
- Related to endocrine and metabolic disorders:
- 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.
- Fasting C-peptide < 1.0 ng/mL.
- Related to other disorders:
- Presence of any severe medical or psychological condition 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.
- Abnormal TSH level (TSH > ULN or < LLN).
- Hemoglobin < 11 g/dL and/or neutrophils < 1,500/mm3 and/or platelets < 100,000/mm3.
- Positive urine pregnancy test.
- Positive urine test for marijuana or hashish metabolites.
- Related to previous or concomitant medications:
- Oral antidiabetic agent except if it is not within 6 months prior to screening visit and only if it was prescribed for no more than 4 months.
- Insulin except if it is not within 6 months prior to screening visit and only for management of gestational diabetes or short-term use to maintain glycemic control for hospitalization, medical procedures, or intervention.
- Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20 mg) Multicenter Study of Long-Term Glycemic Control With Rimonabant in Treatment-naïve Patients With Type 2 Diabetes
Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes
Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight, HDL-cholesterol, triglycerides, blood pressure - Safety, tolerability
Read the detailed description
The total duration of the study will be up to 6 and 1/2 months including screening period (up to 14 days) and double-blind treatment period (approximately 6 months) in patients on mild hypocaloric diet (600 kcal/day deficit).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Rimonabant (SR141716)
- Keywords
- Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimonabant (SR141716)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in HbA1C from baseline to Month 6.
Secondary outcomes (1)
Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257257
- Sponsor's protocol ID
- EFC5825
- Acronym
- SERENADE
- Status last verified
- Apr 2009
- First submitted
- 21 Nov 2005
- Last updated
- 20 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20 mg) Multicenter Study of Long-Term Glycemic Control With Rimonabant in Treatment-naïve Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00257257
- Acronym / sponsor ID
- SERENADE / EFC5825
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 22 Nov 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.
Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes
Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight, HDL-cholesterol, triglycerides, blood pressure - Safety, tolerability
Detailed description
The total duration of the study will be up to 6 and 1/2 months including screening period (up to 14 days) and double-blind treatment period (approximately 6 months) in patients on mild hypocaloric diet (600 kcal/day deficit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients aged greater than or equal to 18 years.
- Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months but no longer than 3 years.
- Type 2 diabetes not previously treated by a pharmacological agent.
- a) insulin use is accepted if it is not within 6 months prior to screening visit and only for the following reasons:
- b) use of an oral antidiabetic agent is accepted if it is not within 6 months prior to screening visit and only if it was prescribed for no more than 4 months.
Key exclusion criteria (26 listed)
- Weight loss > 5 kg within 3 months prior to screening visit.
- Pregnancy or lactation.
- Absence of medically approved contraceptive methods for females of childbearing potential.
- Marijuana or hashish users.
- Administration of other investigational drugs within 30 days prior to screening visit.
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 |
|---|---|---|
| Rimonabant (SR141716) | Drug | – |
Primary outcome
Absolute change in HbA1C from baseline to Month 6.
1 secondary outcome
Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).
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 20 Apr 2009.
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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
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant (SR141716) in people with Type 2 Diabetes Mellitus, run by Sanofi at 7 sites in 7 countries.
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 10 inclusion and 26 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 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Argentina, Chile, Germany, Hungary and 2 more countries. 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. 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 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?
Absolute change in HbA1C from baseline to Month 6.. 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 20 Apr 2009; AzTrials last refreshed its copy on 7 Nov 2026.