NCT00690456|TerminatedPhase 3DMC

Study Stopped

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

Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes

TOCCATA

A Randomized, Double Blind, Placebo Controlled Study Evaluating the Glycemic Effect of Rimonabant Added to Metformin in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC105182007-004833-40

Study Type

interventional

Target

403

Locations

13 countries

Sites

Timeline

RegisteredJun 2008

StartedMay 2008

CompletionFeb 2009

Brief Summary

The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes. Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.

Trial Health

Monitor

Trial Health Score

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

Enrollment

403

participants targeted

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

Timeline

Completed

Started May 2008

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach

13 countries

13 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

9 months study duration

Study Start

First participant enrolled

May 1, 2008

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed

28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

Last Updated

May 18, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

May 7, 2008

Last Update Submit

April 18, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

Randomized Controlled TrialMetformin

Outcome Measures

Primary Outcomes (1)

Change from baseline in HbA1c
36 weeks

Secondary Outcomes (3)

Change from baseline in fasting plasma glucose
36 weeks
Change from baseline in body weight
36 weeks
Percent change from baseline in HDL-C and Triglycerides
36 weeks

Study Arms (2)

Rimonabant

EXPERIMENTAL

Rimonabant 20 mg once daily on top of metformin

Drug: RimonabantDrug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo (for Rimonabant) once daily on top of metformin

Drug: Placebo (for Rimonabant)Drug: Metformin

Interventions

RimonabantDRUG

Tablet, oral administration

Also known as: SR141716, Acomplia

Rimonabant

Placebo (for Rimonabant)DRUG

Tablet, oral administration

Placebo

MetforminDRUG

Metformin continued at stable dose as background therapy

PlaceboRimonabant

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

History of type 2 diabetes
HbA1c between 7% to 10% at screening visit
Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit

You may not qualify if:

Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
Weight loss of more than 5 kg within 3 months prior to screening
Administration of other investigational drugs within 30 days prior to screening visit
Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant
Presence or history of cancer within the past five years
Pregnant or breast-feeding women
Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.
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.