The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
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, safety, and tolerability of 2
      different doses of canagliflozin administered as monotherapy compared with placebo in
      patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
    

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), parallel-group, 3 arm (patients will be assigned to 1 of 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 diagnosed with T2DM who are not
      achieving an adequate response from diet and exercise to control their diabetes.
      Approximately 450 patients with inadequate glycemic control with diet and exercise will
      receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or
      26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg
      (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo
      group to improve glycemic control and remain in the study). Patients will participate in the
      study for approximately 60 to 68 weeks (referred to as the Main Study). The study will also
      include a High Glycemic Substudy in 50 to 100 patients with T2DM who have poorer glycemic
      control with diet and exercise. Patients in the substudy will be assigned to receive
      double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient
      participatation in the substudy will be approximately 34 to 42 weeks. During treatment, if a
      patient's fasting blood sugar remains high despite treatment with study drug and
      reinforcement with diet and exercise, the patient will receive treatment with metformin
      (rescue therapy) consistent with local prescribing information. Study drug will be taken
      orally (by mouth) once daily before the first meal each day unless otherwise specified.
      Patients will take single blind placebo for 1 or 2 weeks (wks) before randomization to the
      Main Study or the High Glycemic Substudy.
    

Intervention name(s): Canagliflozin; Placebo; Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy); One matching placebo capsule orally once daily for 26 weeks (Main Study); One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)
Intervention MeSH terms: Sitagliptin Phosphate; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Canagliflozin; Placebo; Hemoglobin A1c; Type 2 diabetes mellitus