Full Text View
Tabular View
No Study Results Posted
Related Studies
A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes (ALLEGRO)
This study has been terminated.
( Company decision taken in light of demands by certain national health authorities )
First Received: March 19, 2007   Last Updated: June 12, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00449605
  Purpose

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg od versus glimepiride od in reducing 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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: rimonabant (SR141716)
Drug: glimepiride
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy 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

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Change from baseline in glycemic measure HbA1c [ Time Frame: 52 weeks (1 year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute change from baseline in body weight and relative change from baseline in HDL-Cholesterol [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 508
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: rimonabant (SR141716)
on top of metformin
2: Active Comparator Drug: glimepiride
on top of metformin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with legal age
  • Body Mass Index >27kg/m2
  • Type 2 diabetes as defined by 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449605

Locations
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-Aventis
Investigators
Study Director: ICD Sanofi-Aventis
  More Information

No publications provided

Responsible Party: sanofi-aventis ( ICD Study Director )
Study ID Numbers: EFC10007, EUDRACT: 2006-005385-39
Study First Received: March 19, 2007
Last Updated: June 12, 2009
ClinicalTrials.gov Identifier: NCT00449605     History of Changes
Health Authority: United States: Food and Drug Administration;   Mexico: Ministry of Health

Keywords provided by Sanofi-Aventis:
Diabetes
Metformin

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Immunologic Factors
Metformin
Diabetes Mellitus
Endocrine System Diseases
Overweight
Cardiovascular Agents
Immunosuppressive Agents
Glimepiride
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents
Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 02, 2009