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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Obesity

In brief

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.

Key facts

Study ID

NCT02912455

Run by

The Cleveland Clinic

People needed

16

Starts

2017-01-05

Expected to finish

2018-07-19

Last updated by the study team

2020-11-20

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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