The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator 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 and safety of canagliflozin compared
      with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving
      treatment with metformin monotherapy (i.e., treatment with a single drug) 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 nor the study doctor will know the identity of
      assigned study drug), placebo- and active-controlled, parallel-group, 4-arm (4 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) and an active-control (sitagliptin 100 mg, an
      antihyperglycemic agent) in patients with T2DM who are not achieving an adequate response
      from current antihyperglycemic therapy with metformin Immediate Release (IR) to control their
      diabetes. Approximately 1,260 patients with T2DM who are receiving treatment with metformin
      IR and have inadequate glycemic (blood sugar) will receive once-daily treatment with
      canagliflozin (100 mg or 300 mg), sitagliptin 100 mg, or placebo capsules for 26 weeks
      (Period I) followed by another 26-weeks where patients treated with canagliflozin (100 mg or
      300 mg) or sitagliptin 100 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 capsules administered once-daily for 26 weeks (Period II). In addition, all patients will
      take protocol specified stable doses of metformin IR along with assigned study drug for the
      duration of the study. Patients will participate in the study for approximately 59 to 71
      weeks. During the study, if a patient's fasting blood sugar remains high despite treatment
      with study drug, metformin IR, and reinforcement with diet and exercise, the patient will
      receive treatment with glimepiride (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 sign
      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. Patients will take single-blind placebo for 2 weeks before
      randomization. After randomization, patients in the study will take double-blind
      canagliflozin (100 mg or 300 mg) or sitagliptin 100 mg for 52 weeks OR placebo for 26 weeks
      switched to double-blind treatment with sitaliptin 100 mg for 26 weeks.
    

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