CANTATA-MSU study: Evaluation of Canagliflozin for T2DM
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study, to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic control on Metformin and Sulphonylurea Therapy
IRAS ID
46882
Contact name
John Wilding
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2009-016366-88
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The study will assess the effectiveness, safety and tolerability of a new drug, Canagliflozin, in the treatment of subjects with type 2 diabetes mellitus with problems maintaining glucose control on current treatment of metformin and sulphonylurea therapy. Approximately 450 patients will participate and all will receive both Canagliflozin and placebo (dummy tablets), in a random order, during the study. There will be a 2 week screening period before the first dose of drug, followed by 52-week treatment period (consisting of a 26 week double blind treatment period (in which both the investigator or the participant are unaware of the nature of the treatment the participant's receiving) followed by a 26 week extension double blind treatment period (the extension period will provide additional information on longer-term effectiveness and safety compared to dummy tablets). At the end of treatment, there will be a post-treatment phase of approximately 30 days. The total duration of the study for an individual patient will be at least 52 weeks.Throughout the study subjects will be assessed using a number of methods including glucose monitoring, urine and blood sample collection, waist measurement and paper questionnaires.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
10/H0402/23
Date of REC Opinion
26 Apr 2010
REC opinion
Further Information Favourable Opinion