A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
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 older patients (55 to 80 years of age) with type 2
      diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.
    

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 to control their diabetes. Approximately 720 older (55 to
      80 years of age) patients with T2DM who are either not on an antihyperglycemic agent or who
      are receiving treatment with a stable regimen of antihyperglycemic agent(s) and have
      inadequate glycemic (blood sugar) control will receive once daily treatment with
      canagliflozin (100 mg or 300 mg) or placebo capsules for 104 weeks (includes 26 weeks of
      double-blind treatment followed by a 78-week extension period). In addition, all patients
      will take stable doses of the antihyperglycemic agent(s) that they were taking before entry
      in the study for the duration of the study. Patients will participate in the study for
      approximately 108 weeks. During the study, if a patient's fasting blood sugar remains high
      despite treatment with study drug, the patient will receive treatment with an
      antihyperglycemic agent (rescue therapy) that is considered clinically appropriate and
      consistent with local prescribing information. During treatment, patients will be monitored
      for safety by review of adverse events, results from laboratory tests, measures of bone
      health, 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. 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 104 weeks.
    

Intervention name(s): Canagliflozin 100 mg; Canagliflozin 300 mg; Antihyperglycemic agent(s); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.; One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.; Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4] inhibitors, metformin, insulin [all types]) and their combinations (sulfonylurea agent and insulin [all types], metformin and insulin [all types], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4]) are used as per protocol specifications.; One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
Intervention MeSH terms: Canagliflozin; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Canagliflozin; Placebo; Hemoglobin A1c; Bone; Type 2 diabetes mellitus