The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)
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
      receving treatment with metformin and pioglitazone 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), 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 pioglitazone to control their diabetes.
      Approximately 360 patients with T2DM who are receiving combination therapy with metformin and
      pioglitazone will receive the addition of once-daily treatment with canagliflozin (100 mg or
      300 mg) or placebo capsules for 26 weeks followed by a 26-week extension period where
      patients treated with canagliflozin (100 mg or 300 mg) will continue treatment for an
      additional 26 weeks and patients treated with placebo will be switched to active double-blind
      treatment with sitagliptin 100 mg, an antihyperglycemic agent administered once-daily for 26
      weeks. In addition, all patients will take protocol specified stable doses of metformin and
      pioglitazone along with assigned study drug for the duration of the study. Patients will
      participate in the study for approximately 59 to 78 weeks. During the study, if a patient's
      fasting blood sugar remains high despite treatment with study drug, the patient will receive
      treatment with glimepiride (rescue therapy) in accordance 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 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. 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) for 52 weeks OR placebo for
      26 weeks switched to double-blind sitagliptin 100 mg for 26 weeks.
    

Intervention name(s): Placebo; Canagliflozin; Sitagliptin; Metformin; Pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.; One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.; One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.; The patient's stable dose of metformin background therapy should be continued throughout the study.; The patient's stable dose of pioglitazone background therapy should be continued throughout the study.
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Canagliflozin; Placebo; Sitagliptin (Januvia); Metformin; Pioglitazone (Actos); Hemoglobin A1c; Type 2 diabetes mellitus