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

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT00449605

Collaborator

(none)

508

Enrollment

Locations

Arms

Duration (Months)

33.9

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Mar 1, 2007

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

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

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

Primary Outcome Measures

Change from baseline in glycemic measure HbA1c [52 weeks (1 year)]

Secondary Outcome Measures

Absolute change from baseline in body weight [52 weeks]
Relative change from baseline in HDL-C [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Santiago		Chile
3	Sanofi-aventis adminsitrative office	Santiago		Chile
4	Sanofi-Aventis Administrative Office	Horsholm		Denmark
5	Sanofi-Aventis Administrative Office	Helsinki		Finland
6	Sanofi-Aventis Administrative Office	Budapest		Hungary
7	Sanofi-Aventis Administrative Office	Mumbai		India
8	Sanofi-Aventis Administrative Office	Milan		Italy
9	Sanofi-Aventis Administrative Office	Seoul		Korea, Republic of
10	Sanofi-Aventis Administrative Office	Mexico		Mexico
11	Sanofi-Aventis Administrative Office	Puerto Rico		Puerto Rico
12	Sanofi-Aventis Administrative Office	Bucuresti		Romania
13	Sanofi-Aventis Administrative Office	Moscow		Russian Federation
14	Sanofi-Aventis Administrative Office	Barcelona		Spain
15	Sanofi-Aventis Administrative Office	Bromma		Sweden