The CANTATA-MP Trial - Evaluation of Canagliflozin for T2DM

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26 Week Multicenter Study with a 26-Week Extension to Evaluate the Efficacy, Safety, and Tolerability of JNJ 28431754 (Canagliflozin) Compared with Placebo in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy

• IRAS ID

  57918

• Contact name

  Barry Silvert

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2009-018070-64

• 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 pioglitazone therapy. Approximately 360 patients will participate and all will receive both Canagliflozin and placebo (dummy tablets), in a random order, during the study. There will be a 3 week screening period before the first dose of drug, followed by 52-week treatment period. the treatment period will consist 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 is receiving) followed by a 26-week double blind treatment period (during which Participants previously receiving placebo will be switched in a blinded fashion to active-contol therapy with Sitagliptin 100mg once daily and will continue this treatment within the 26-week double blind extension period).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, and waist measurement.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/62

• Date of REC Opinion

  8 Oct 2010

• REC opinion

  Further Information Favourable Opinion