The Effect of add-on Canagliflozin in Patients With Type 2 Diabetes Treated With U-500 Insulin

• Status: Withdrawn
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the effect of adding a SGLT-2 inhibitor (namely Canagliflozin) on the dose of U-500 insulin required to achieve glycemic control in patients with type 2 diabetes. We hypothesize that adding Canagliflozin to patients treated with U-500 insulin may result in significant reduction in insulin dose due to improved insulin sensitivity and weight loss.

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

Details

• Lead Sponsor: Joslin Diabetes Center
• Treatments: Canagliflozin; Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Subject with type 2 diabetes

• Subject is managed on ≥200 units of U-500 insulin plus or minus stable dose of oral antihyperglycemic medications for at least 3 months (dose of oral antihyperglycemic medications will remain stable during intervention)

• Subject is male or non-pregnant and non-lactating female

• Subject with BMI > 25 kg/m2

• Subject with A1C >7%

• Subject with serum potassium between 5-5.5 mEq/L

• If subject is on chronic medications such as anti-hypertensive, lipid-lowering medications, thyroid medication or hormonal therapy, the dose of these medications should be stable for at least three months prior to the screening visit. These medications will not be changed during the intervention period unless mandatory

Exclusion Criteria:

• Subject has history of renal disease (serum creatinine >1.5mg/dL or GFR <60 mL/min/1.73 m2).

• Subject has history of recurrent urinary tract infections

• Subject has history of urinary incontinence

• Subject has history of prostate hypertrophy

• Subject has history of cancer bladder or cancer prostate

• Subject has history of hematuria

• Subject using corticosteroid treatment, except inhaled or topical steroids

• Subject having an active malignancy (excluding the following dermal malignancies:

basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).

• Subject states that he/she had a recent cardiovascular event (e.g. myocardial infarction, stroke) ≤ six months prior to the screening visit; or stated that he/she had history of congestive heart failure.

• Subject has hepatic failure or had status post organ transplant

• Subject has any chronic, contagious or infectious diseases

• Subject has blood clotting or bleeding disorders