An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type II; Diabetes Mellitus, Non Insulin Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness, safety, and tolerability of
      JNJ-28431754 compared with placebo in patients with type 2 diabetes.
    

Detailed description: 
      Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion
      of insulin by the pancreas and resistance to the action of insulin in various tissues
      (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia
      leads to progressive impairment of insulin secretion and to insulin resistance of peripheral
      tissues in diabetes (so-called glucose toxicity), which further worsens control of blood
      glucose. In addition, chronic hyperglycemia is a major risk factor for complications,
      including heart disease, retinopathy, nephropathy, and neuropathy. Although numerous
      treatments have been developed for the treatment of diabetes and individual agents may be
      highly effective for some patients, it is still difficult to maintain optimal glycemic
      control in most patients with diabetes. This is a randomized, double-blind,
      placebo-controlled, parallel group, multicenter, dose-ranging study to determine the
      efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with
      placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is
      that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from
      baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be
      monitored throughout the study using spontaneous adverse event reporting, clinical laboratory
      tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes,
      assessment of urinary albumin excretion and markers of proximal renal tubular function;
      pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations,
      assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and
      hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample
      collection for fungal and bacterial culture in subjects with symptoms consistent with
      vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).
    

Intervention name(s): Canagliflozin (JNJ-28431754); Sitagliptin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.; One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.; One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.
Other intervention name(s): JNJ-28431754
Intervention MeSH terms: Sitagliptin Phosphate; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Metformin; Hemoglobin A1c