CARAT: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: canagliflozin; Placebo (for canagliflozin)
Intervention description: encapsulated (gelatin capsule).; encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.
Intervention MeSH terms: Canagliflozin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Post-Bariatric Surgery; hemoglobin A1c protein, human

Summary:

      This is a prospective, randomized clinical trial for patients with recurrent type 2 diabetes
      post-gastric bypass surgery that will compare a 6 month course of canagliflozin monotherapy
      vs. placebo on clinical outcomes of type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post Roux-n-Y gastric bypass (RYGB) surgery and sleeve gastrectomy (SG) patients who
             underwent surgery >1 and <15 years ago in the Cleveland surrounding area

          -  Age 20-75 years of age

          -  Type II Diabetes Mellitus (D2M) diagnosis (history, medication usage, biochemical
             criteria) prior to and after surgery; after surgery, defined by a single HbA1c of
             greater or equal to 6.5% at consent and screening.

          -  Metformin patients must have an HbA1c greater than or equal to 6.5% but less than or
             equal to 10% at randomization; for diet controlled patients (i.e. not on any T2D
             medication), HbA1c must be greater than or equal to 6.5% at randomization.

          -  Patient reporting of improvement in T2D status or objective improvements in T2D status
             at any time post-surgery.

          -  estimated glomerular filtration rate (eGFR) ≥ 60mL/min prior to randomization

          -  Has the ability and willingness to provide informed consent.

          -  Is able to understand the options and to comply with the requirements of each program

          -  Female subject agrees to have a serum pregnancy test at screening. A negative serum
             pregnancy test result is required prior to randomization.

          -  Female patients must agree to use a reliable method of contraception for 6 months or
             duration of intervention

          -  Patients taking an anti-diabetic medication, except insulin, are eligible and must
             agree to washout for 8 weeks prior to the randomization visit.

        Exclusion Criteria:

          -  Type 1 diabetes indicated by history of diabetic ketoacidosis and lack of remission in
             response to bariatric surgery

          -  Other post bariatric procedures (banding, duodenal switch, biliopancreatic diversion)

          -  Current use of insulin.

          -  End organ diabetic complications (renal failure, cardiomyopathy, severe
             neuropathy/foot ulcers)

          -  Documented severe or unstable depression/anxiety or eating disorder that would not
             enable patient to adhere to anti-diabetic treatment

          -  Clinical contraindications to use canagliflozin, i.e., history of bladder cancer,
             Child-Pugh class C