Diabetes Mellitus, Type 2Phase 3NCT00754689
Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes
A Phase 3 study testing Rimonabant and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in United States.
Trial summary
The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rimonabant and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Nov 2008
- 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
- History of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ADA criteria)
- Patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline A1C assessment in all patients
- A1C ≥7.0 % and ≤10.0 %
- Fasted plasma glucose at screening visit ≤260 mg/dL (14.44 mmol/L)
Who cannot join
- Treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
- In the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
- Presence or history of cancer within the past five years
- Pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control
- 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.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Multicenter, Double Blind, Placebo Controlled Randomized Study of the Efficacy and Safety of Two Rimonabant/Metformin Combinations for Reducing A1C in the Treatment of Patients With Type 2 Diabetes Mellitus Who Are Not on Current Drug Therapy.
The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months.
The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months.
Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.
Read the detailed description
The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rimonabant, Metformin, placebo
- Keywords
- Rimonabant/metformin combination
- 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.
RimonabantDrug
Also called SR141716, Acomplia
Tablet, oral administration
MetforminDrug
Tablet, oral administration
placeboDrug
Tablet, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Metformin 500mg twice daily (bid) + placebo Receives: Drug: Metformin; Drug: placebo |
| Arm 2 | Active comparator | Metformin 1000mg bid + placebo Receives: Drug: Metformin; Drug: placebo |
| Arm 3 | Active comparator | Rimonabant 20mg once daily (od) + placebo Receives: Drug: Rimonabant; Drug: placebo |
| Arm 4 | Experimental | Rimonabant 10mg bid (from week 2) in combination with metformin 500mg bid Receives: Drug: Rimonabant; Drug: Metformin |
| Arm 5 | Experimental | Rimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid Receives: Drug: Rimonabant; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in A1C
Measured: at 9 months
Secondary outcomes (4)
Change from baseline in fasting plasma glucose
Measured: at 9 months
Change from baseline in body weight
Measured: at 9 months
Percent change from baseline in triglycerides
Measured: at 9 months
Percent change from baseline in HDL-C
Measured: at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionNov 2008
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 Diabetes Mellitus, Type 2Studies 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
- 0 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
- NCT00754689
- Sponsor's protocol ID
- EFC10231
- Other IDs
- 2008-002500-26, 2008
- Status last verified
- May 2016
- First submitted
- 17 Sep 2008
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double Blind, Placebo Controlled Randomized Study of the Efficacy and Safety of Two Rimonabant/Metformin Combinations for Reducing A1C in the Treatment of Patients With Type 2 Diabetes Mellitus Who Are Not on Current Drug Therapy.
- ClinicalTrials.gov ID
- NCT00754689
- Acronym / sponsor ID
- EFC10231
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Rimonabant/metformin combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Sep 2008 (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 the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months.
The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months.
Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.
Detailed description
The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Metformin, Drug: placeboMetformin 500mg twice daily (bid) + placebo |
| Arm 2 | Active comparator | Drug: Metformin, Drug: placeboMetformin 1000mg bid + placebo |
| Arm 3 | Active comparator | Drug: Rimonabant, Drug: placeboRimonabant 20mg once daily (od) + placebo |
| Arm 4 | Experimental | Drug: Rimonabant, Drug: MetforminRimonabant 10mg bid (from week 2) in combination with metformin 500mg bid |
| Arm 5 | Experimental | Drug: Rimonabant, Drug: MetforminRimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ADA criteria)
- Patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline A1C assessment in all patients
- A1C ≥7.0 % and ≤10.0 %
- Fasted plasma glucose at screening visit ≤260 mg/dL (14.44 mmol/L)
Key exclusion criteria (6 listed)
- Treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
- In the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
- Presence or history of cancer within the past five years
- Pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control
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 | Arm 3, Arm 4, Arm 5 |
| MetforminTablet, oral administration | Drug | Arm 1, Arm 2, Arm 4, Arm 5 |
| placeboTablet, oral administration | Drug | Arm 1, Arm 2, Arm 3 |
Primary outcome
Change from baseline in A1C
Time frame: at 9 months
4 secondary outcomes
Change from baseline in fasting plasma glucose
Time frame: at 9 months
Change from baseline in body weight
Time frame: at 9 months
Percent change from baseline in triglycerides
Time frame: at 9 months
Percent change from baseline in HDL-C
Time frame: at 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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 and Metformin in people with Diabetes Mellitus, Type 2, 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 6 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: withdrawn, as of the sponsor's last update on 17 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in A1C (time frame: at 9 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 17 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.