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.
Drug: Placebo (for canagliflozin)
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Full eligibility criteria for NCT02912455
Ages eligible for Study
20 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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
All locations for NCT02912455
United States (1)
Cleveland, Ohio, United States, 44195
View full eligibility
Tris trial is registered with FDA with number: NCT02912455. The sponsor of the trial is The Cleveland Clinic and it is looking for 16 volunteers for the current phase.
Official trial title: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes
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