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A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes (ALLEGRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief 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) 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

Detailed Description:
The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.
Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rimonabant
Rimonabant 20 mg once daily on top of metformin
 Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia

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:
  • HOE490
  • Amaryl

Drug: Metformin
Metformin continued at stable dose as background therapy


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in glycemic measure HbA1c [ Time Frame: 52 weeks (1 year) ]

Secondary Outcome Measures :
  1. Absolute change from baseline in body weight [ Time Frame: 52 weeks ]
  2. Relative change from baseline in HDL-C [ Time Frame: 52 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD Sanofi
More Information
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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
Keywords provided by Sanofi:
Diabetes
Metformin
Additional relevant MeSH terms:
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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