Canagliflozin-Mealtime Insulin Rescue

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy of canagliflozin as compared with placebo in reducing the need for mealtime insulin in subjects with type 2 diabetes currently using a basal-bolus insulin regimen.

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

Details

• Lead Sponsor: Atlanta Research and Education Foundation; Foundation for Atlanta Veterans Education and Research, Inc.
• Collaborator: Janssen Scientific Affairs, LLC
• Treatments: Canagliflozin

Criteria

Inclusion Criteria:

• use of basal-bolus insulin

• onset of diabetes after age 30

• BMI less than 35

• eGFR at least 60 ml/mn

• Hb A1c 7.0-10.0%

• willingness to perform home glucose monitoring

• willingness to transmit glucose and medication information weekly

Exclusion Criteria:

• Type 1 diabetes

• Known peripheral artery disease

• Liver enzymes equal or more than 1.5 times the upper limit of normal

• Chronic heart failure NYHA class III or IV

• Current haemodialysis or peritoneal dialysis

• End stage liver disease, defined as acute or chronic liver disease and recent history of one of the following: ascites, encephalopathy, variceal bleeding, bilirubin equal or greater than 2.0 mg/dL, albumin equal or less than 3.5 g/ dL, prothrombin time greater or equal to 4 seconds, INR greater than or equal to 1.7 or prior liver transplant

• Known or suspected hypersensitivity to trial products or related products

• Female of child-bearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods as required by law or local practice.

• Expected simultaneous participation in any other clinical trial of an investigational medicinal product.

• Receipt of any investigational medicinal product within 30 days before randomization

• Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)

• Any condition that in the investigator's opinion would make the subject unable to adhere to the trial visit schedule and procedures

• Known history of non-compliance to treatment.