Diabetes Mellitus, Type 2Phase 3ALLEGRONCT00449605
A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
A Phase 3 study testing Rimonabant, Glimepiride and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 15 sites in 14 countries.
Trial summary
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day)… 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, Glimepiride and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 15 sitesin 14 countries
- Study dates
- Mar 2007to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with legal age
- Body Mass Index >27kg/m2
- Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three months
- HbA1c >=7% and <=9% at screening visit
Who cannot join
- Weight loss > 5 kg within three months prior to screening
- Presence of any clinically significant endocrine disease according to the Investigator
- Presence of type 1 diabetes
- Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
- Previous participation in a clinical study with rimonabant
- Absence of effective medical contraceptive method for females of childbearing potential
Show all 10Show fewer
- Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
- Within 2 months 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
- 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, including uncontrolled serious psychiatric illness
- 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
15 sites in 14 countries.
15 sites in 14 countries
Chile2 sites
Sanofi-Aventis Administrative Office
Santiago
Sanofi-aventis adminsitrative office
Santiago
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.
The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
Read the detailed description
The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rimonabant, Glimepiride, Metformin
- Keywords
- Diabetes, Metformin
- Medical subject headings
- 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
GlimepirideDrug
Also called HOE490, Amaryl
Tablet, oral administration
MetforminDrug
Metformin continued at stable dose as background therapy
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Experimental | Rimonabant 20 mg once daily on top of metformin Receives: Drug: Rimonabant; Drug: Metformin |
| Glimepiride | Active comparator | Glimepiride from 1 mg up to 6 mg once daily on top of metformin Receives: Drug: Glimepiride; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycemic measure HbA1c
Measured: 52 weeks (1 year)
Secondary outcomes (2)
Absolute change from baseline in body weight
Measured: 52 weeks
Relative change from baseline in HDL-C
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2008
- 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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449605
- Sponsor's protocol ID
- EFC10007
- Other IDs
- 2006-005385-39
- Acronym
- ALLEGRO
- Status last verified
- Apr 2016
- First submitted
- 19 Mar 2007
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin
- ClinicalTrials.gov ID
- NCT00449605
- Acronym / sponsor ID
- ALLEGRO / EFC10007
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Metformin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 508 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Mar 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 is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.
The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
Detailed description
The total duration per patient will be approximately 65 weeks including a 52-week 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: Rimonabant, Drug: MetforminRimonabant 20 mg once daily on top of metformin |
| Glimepiride | Active comparator | Drug: Glimepiride, Drug: MetforminGlimepiride from 1 mg up to 6 mg once daily on top of metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with legal age
- Body Mass Index >27kg/m2
- Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three months
- HbA1c >=7% and <=9% at screening visit
Key exclusion criteria (10 listed)
- Weight loss > 5 kg within three months prior to screening
- Presence of any clinically significant endocrine disease according to the Investigator
- Presence of type 1 diabetes
- Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
- Previous participation in a clinical study with rimonabant
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 |
| GlimepirideAlso: HOE490, AmarylTablet, oral administration | Drug | Glimepiride |
| MetforminMetformin continued at stable dose as background therapy | Drug | Glimepiride, Rimonabant |
Primary outcome
Change from baseline in glycemic measure HbA1c
Time frame: 52 weeks (1 year)
2 secondary outcomes
Absolute change from baseline in body weight
Time frame: 52 weeks
Relative change from baseline in HDL-C
Time frame: 52 weeks
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 16 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 study director
Sanofi
15 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant, Glimepiride and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 15 sites in 14 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 4 inclusion and 10 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 16 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 15 sites in Chile, United States, Denmark, Finland, Hungary and 9 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 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?
Change from baseline in glycemic measure HbA1c (time frame: 52 weeks (1 year)). 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 16 May 2016.