CARAT: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes

• Status: Terminated
• Trial end date: 2018-07-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Canagliflozin

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