Diabetes Mellitus, Type 2Phase 3REASSURENCT00546325
REASSURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
A Phase 3 study testing Rimonabant in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Australia.
Trial summary
Primary: To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- 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
- 358 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2007to Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of Type 2 diabetes
- HbA1c between 7% to 9% (inclusive)
- BMI ≥ 27kg/m² and BMI ≤ 40kg/m²
- Currently taking Metformin and Sulfonylurea.
Who cannot join
- Uncontrolled serious psychiatric illness such as major depression
- Current use of antidepressants
- Severe renal impairment (creatinine clearance less than 30ml/min)
- Severe hepatic impairment known by investigator or Aspartate Aminotransferase and/or Alanine Aminotransferase > 3 times Upper Limit Normal
- Patient treated for epilepsy
- Pregnant or breast-feeding women
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- Women of childbearing potential not protected by effective contraception
- Hypersentivity/intolerance to rimonabant or any of the excipents
- Presence of any condition, current or anticipated that in the investigator's opinion would compromise the patient's safety
- Use of insulin for longer than 1 week within 4 weeks prior to screening
- Chronic use of systemic corticosteriods
- Use of glitazone therapy, glucagon-like peptide or dipeptidyl peptidase IV
- History of drug or alcohol abuse wihtin the last three years
- Heart failure class III-IV (New York Heart Association classification)
- Severe hypertension
- Adminstration of the following medications: phentermine, amphetamines, orlistat, sibutramine, herbal remedies
- Use of non-lipid agents known to affect lipid metabolism: retinoids, antiretrovirals, hormone replacement therapy containing estrogens, cyclosporin, thiazolidinediones (glitazones), fish oils, plant sterols
- Use of ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, phenobarbitone, carbamazepine or St John's Wort
- Participation in a clinical study within the 4 weeks prior to randomisation
- Patients involved in an existing weight loss program
- Presence of chronic hepatitis
- Use, or misuse, of substances of abuse
- Marijuana or hashish users
- History of gastrointestinal surgery for weight loss purposes or who are scheduled for such surgery within the duration of their expected participation in this study
- History or presence of bulimia or laxative abuse
- Non-English speaking
- 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: REASURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
Primary:
To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met) and Sulfonylurea (SU).
Secondary:
To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid measures, Other measures and changes in quality of life
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rimonabant, Placebo
- 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
White opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast
PlaceboDrug
Matching placebo tablets. Once daily before breakfast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rimonabant Receives: Drug: Rimonabant |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in HbA1c between both placebo and rimonabant group.
Measured: From baseline to week 48
Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%
Measured: From the beginning to the end of the study
Percentage of participants responding to treatment
Measured: From the beginning to the end of study
Rate of asymptomatic, symptomatic, and severe hypoglycaemia
Measured: From the beginning to the end of the study
Change in physical examinations, vital signs, laboratory parameters, adverse events
Measured: From the beginning to the end of the study
Secondary outcomes (5)
Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.
Measured: From the beginning to the end of the study
Change in BMI, waist and hip circumference, waist/hip ratio, weight
Measured: From the beginning to the end of the study
Changes in Quality of Life
Measured: From the beginning to the end of the study
Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)
Measured: From administration of drug till end of study
Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio
Measured: From administration of drug to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2009
- Study completionFeb 2009
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
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David WHEATLEY, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546325
- Sponsor's protocol ID
- RIMON_L_01661
- Acronym
- REASSURE
- Status last verified
- Dec 2010
- First submitted
- 17 Oct 2007
- Last updated
- 10 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REASURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
- ClinicalTrials.gov ID
- NCT00546325
- Acronym / sponsor ID
- REASSURE / RIMON_L_01661
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Oct 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.
Primary:
To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met) and Sulfonylurea (SU).
Secondary:
To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid measures, Other measures and changes in quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RimonabantRimonabant |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of Type 2 diabetes
- HbA1c between 7% to 9% (inclusive)
- BMI ≥ 27kg/m² and BMI ≤ 40kg/m²
- Currently taking Metformin and Sulfonylurea.
Key exclusion criteria (27 listed)
- Uncontrolled serious psychiatric illness such as major depression
- Current use of antidepressants
- Severe renal impairment (creatinine clearance less than 30ml/min)
- Severe hepatic impairment known by investigator or Aspartate Aminotransferase and/or Alanine Aminotransferase > 3 times Upper Limit Normal
- Patient treated for epilepsy
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 |
|---|---|---|
| RimonabantWhite opaque film-coated, for oral administration containing 20 mg of active rimonabant. Once daily before breakfast | Drug | 1 |
| PlaceboMatching placebo tablets. Once daily before breakfast | Drug | 2 |
Primary outcome
Absolute change in HbA1c between both placebo and rimonabant group.
Time frame: From baseline to week 48
Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%
Time frame: From the beginning to the end of the study
Percentage of participants responding to treatment
Time frame: From the beginning to the end of study
Rate of asymptomatic, symptomatic, and severe hypoglycaemia
Time frame: From the beginning to the end of the study
Change in physical examinations, vital signs, laboratory parameters, adverse events
Time frame: From the beginning to the end of the study
5 secondary outcomes
Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.
Time frame: From the beginning to the end of the study
Change in BMI, waist and hip circumference, waist/hip ratio, weight
Time frame: From the beginning to the end of the study
Changes in Quality of Life
Time frame: From the beginning to the end of the study
Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)
Time frame: From administration of drug till end of study
Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio
Time frame: From administration of drug to end of study
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 10 Dec 2010.
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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.
David WHEATLEY 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 Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Australia.
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 27 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 10 Dec 2010. 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 Australia. 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 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 between both placebo and rimonabant group. (time frame: From baseline to week 48). The study lists 5 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 10 Dec 2010.