The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of 2 different doses of
      canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are
      receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood
      sugar) control.
    

Detailed description: 
      Canagliflozin is a drug that is being tested to see if it may be useful in treating patients
      diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by
      chance), double-blind (neither the patient or the study doctor will know the name of the
      assigned treatment), placebo-controlled, parallel-group, 3-arm (3 treatment groups)
      multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100
      mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but
      has no real medicine) in patients with T2DM who are not achieving an adequate response from
      current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes.
      Approximately 450 patients with T2DM who are receiving treatment with metformin and
      sulphonylurea and have inadequate glycemic (blood sugar) control will receive once daily
      treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 52 weeks (includes 26
      weeks of double-blind treatment followed by a 26-week extension period). In addition, all
      patients will take protocol-specified stable doses of metformin and sulphonylurea for the
      duration of the study. Patients will participate in the study for approximately 59 to 72
      weeks. During the study, if a patient's fasting blood sugar remains high despite treatment
      with study drug, the patient will receive treatment with insulin (rescue therapy) consistent
      with local prescribing information. During treatment, patients will be monitored for safety
      by review of adverse events, results from laboratory tests, 12-lead electrocardiograms
      (ECGs), vital signs measurements, body weight, physical examinations, and self-monitored
      blood glucose (SMGB) measurements. The primary outcome measure in the study is to assess the
      effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of
      treatment. Study drug will be taken orally (by mouth) once daily before the first meal each
      day unless otherwise specified. All patients will take single-blind placebo capsules for 2
      weeks before randomization. After randomization, patients will take double-blind
      canagliflozin (100 mg or 300 mg) or matching placebo for 52 weeks.
    

Intervention name(s): Canagliflozin; Placebo; Metformin; Sulphonylruea
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.; One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.; The patient's stable dose of background metformin therapy should be continued throughout the study.; The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Canagliflozin; Placebo; Metformin; Sulphonylurea; Hemoglobin A1c; Type 2 diabetes mellitus