NCT00449605|TerminatedPhase 3DMC

Study Stopped

Company decision taken in light of demands by certain national health authorities

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

ALLEGRO

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

Sanofi ClinicalTrials.gov

Compare

2 other identifiers

EFC100072006-005385-39

Study Type

interventional

Target

508

Locations

14 countries

Sites

Timeline

RegisteredMar 2007

StartedMar 2007

CompletionMar 2009

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

508

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started Mar 2007

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach

14 countries

15 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

March 1, 2007

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed

Last Updated

May 16, 2016

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

March 19, 2007

Last Update Submit

April 13, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesMetformin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (2)

Rimonabant

EXPERIMENTAL

Rimonabant 20 mg once daily on top of metformin

Drug: RimonabantDrug: Metformin

Glimepiride

ACTIVE COMPARATOR

Glimepiride from 1 mg up to 6 mg once daily on top of metformin

Drug: GlimepirideDrug: Metformin

Interventions

RimonabantDRUG

Tablet, oral administration

Also known as: SR141716, Acomplia

Rimonabant

GlimepirideDRUG

Tablet, oral administration

Also known as: HOE490, Amaryl

Glimepiride

MetforminDRUG

Metformin continued at stable dose as background therapy

GlimepirideRimonabant

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.