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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

Tracking Information
First Submitted Date  ICMJE March 19, 2007
First Posted Date  ICMJE March 20, 2007
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE March 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2008)
Change from baseline in glycemic measure HbA1c [ Time Frame: 52 weeks (1 year) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2007)
Change in glycemic measure HbA1c from baseline to 52 weeks (1 year).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2016)
  • Absolute change from baseline in body weight [ Time Frame: 52 weeks ]
  • Relative change from baseline in HDL-C [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2007)
Absolute change in body weight from baseline to 1 year and relative change in HDL-Cholesterol from baseline to 1 year.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
Official Title  ICMJE 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
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.

Detailed Description The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Rimonabant
    Tablet, oral administration
    Other Names:
    • SR141716
    • Acomplia
  • Drug: Glimepiride
    Tablet, oral administration
    Other Names:
    • HOE490
    • Amaryl
  • Drug: Metformin
    Metformin continued at stable dose as background therapy
Study Arms  ICMJE
  • Experimental: Rimonabant
    Rimonabant 20 mg once daily on top of metformin
    Interventions:
    • Drug: Rimonabant
    • Drug: Metformin
  • Active Comparator: Glimepiride
    Glimepiride from 1 mg up to 6 mg once daily on top of metformin
    Interventions:
    • Drug: Glimepiride
    • Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2009)
508
Original Enrollment  ICMJE
 (submitted: March 19, 2007)
500
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Denmark,   Finland,   Hungary,   India,   Italy,   Korea, Republic of,   Mexico,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Sweden,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00449605
Other Study ID Numbers  ICMJE EFC10007
2006-005385-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sanofi
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Sanofi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD Sanofi
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP