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

• ClinicalTrials.gov Identifier: NCT00449605
• Recruitment Status: Terminated
• First Posted: March 20, 2007
• Last Update Posted: May 16, 2016
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: March 19, 2007
• First Posted Date: March 20, 2007
• Last Update Posted Date: May 16, 2016
• Study Start Date: March 2007
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 19, 2008): Change from baseline in glycemic measure HbA1c [ Time Frame: 52 weeks (1 year) ]
• Original Primary Outcome Measures (submitted: March 19, 2007): Change in glycemic measure HbA1c from baseline to 52 weeks (1 year).

Current Secondary Outcome Measures (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 (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: A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
• 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

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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 2

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 12, 2009): 508
• Original Enrollment (submitted: March 19, 2007): 500
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT00449605
• Other Study ID Numbers: EFC10007; 2006-005385-39 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi
• Original Responsible Party: Not Provided
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ICD; Sanofi

• PRS Account: Sanofi
• Verification Date: April 2016