A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes (ALLEGRO)
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ClinicalTrials.gov Identifier: NCT00449605 |
Recruitment Status :
Terminated
(Company decision taken in light of demands by certain national health authorities)
First Posted : March 20, 2007
Last Update Posted : May 16, 2016
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Rimonabant Drug: Glimepiride Drug: Metformin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 508 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Rimonabant
Rimonabant 20 mg once daily on top of metformin
|
Drug: Rimonabant
Tablet, oral administration
Other Names:
Drug: Metformin Metformin continued at stable dose as background therapy |
Active Comparator: Glimepiride
Glimepiride from 1 mg up to 6 mg once daily on top of metformin
|
Drug: Glimepiride
Tablet, oral administration
Other Names:
Drug: Metformin Metformin continued at stable dose as background therapy |
- Change from baseline in glycemic measure HbA1c [ Time Frame: 52 weeks (1 year) ]
- Absolute change from baseline in body weight [ Time Frame: 52 weeks ]
- Relative change from baseline in HDL-C [ Time Frame: 52 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449605
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Chile | |
Sanofi-Aventis Administrative Office | |
Santiago, Chile | |
Sanofi-aventis adminsitrative office | |
Santiago, Chile | |
Denmark | |
Sanofi-Aventis Administrative Office | |
Horsholm, Denmark | |
Finland | |
Sanofi-Aventis Administrative Office | |
Helsinki, Finland | |
Hungary | |
Sanofi-Aventis Administrative Office | |
Budapest, Hungary | |
India | |
Sanofi-Aventis Administrative Office | |
Mumbai, India | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milan, Italy | |
Korea, Republic of | |
Sanofi-Aventis Administrative Office | |
Seoul, Korea, Republic of | |
Mexico | |
Sanofi-Aventis Administrative Office | |
Mexico, Mexico | |
Puerto Rico | |
Sanofi-Aventis Administrative Office | |
Puerto Rico, Puerto Rico | |
Romania | |
Sanofi-Aventis Administrative Office | |
Bucuresti, Romania | |
Russian Federation | |
Sanofi-Aventis Administrative Office | |
Moscow, Russian Federation | |
Spain | |
Sanofi-Aventis Administrative Office | |
Barcelona, Spain | |
Sweden | |
Sanofi-Aventis Administrative Office | |
Bromma, Sweden |
Study Director: | ICD | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00449605 |
Other Study ID Numbers: |
EFC10007 2006-005385-39 ( EudraCT Number ) |
First Posted: | March 20, 2007 Key Record Dates |
Last Update Posted: | May 16, 2016 |
Last Verified: | April 2016 |
Diabetes Metformin |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Glimepiride Rimonabant Hypoglycemic Agents Physiological Effects of Drugs |
Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors Anti-Obesity Agents Cannabinoid Receptor Antagonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |