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

Conditions

• Diabetes, Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Canagliflozin — DRUG

Study Details

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.

Key Dates

Start date

Nov 30, 2015

Status verified

Feb 2017

Primary completion

Jul 31, 2017

Completion

Jul 31, 2017

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Intervention Group
  Subjects in this group will take canagliflozin in addition to their regular U-500 insulin dose and other antihyperglycemic medications. Canagliflozin dose will be titrated after 2 weeks from 100 mg once daily to 300 mg once daily. This dose will continue for 22 weeks.
• Placebo Comparator: Control Group
  Subjects in this group will take a matched placebo in addition to their regular U-500 insulin dose and other antihyperglycemic medications for 2 weeks then another matched-placebo for 22 weeks.

Primary Outcome Measure

Reduction in insulin recuirement [ Time Frame: Twenty four weeks ]

Locations (1)

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