Canagliflozin-Mealtime Insulin Rescue

August 12, 2022 updated by: Foundation for Atlanta Veterans Education and Research, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The Canagliflozin Mealtime Insulin Rescue study will enroll up to 40 subjects at the Atlanta VA Medical Center. Subjects will be screened and enter a 2-week run-in period during which they will switch to or continue on a diabetes treatment regimen of basal insulin before supper and aspart insulin before meals. Run-in will be useful in evaluating compliance to treatment and self-monitoring. After run-in, subjects will collect one week of baseline glycemic data with regular pre-meal and fasting glycemic levels using both finger stick testing and continuous glucose monitoring.

Subjects will be randomized at Visit 3 to 100 mg of canagliflozin or placebo. If well tolerated, this dose will be increased to 300 mg of canagliflozin or placebo at Visit 4.

Diabetes management will be assured through regular contact with the study team (weekly calls and clinic visits at Weeks 4, 8, 16 and 24). Management will be facilitated by diabetes management software. Self-monitoring and continuous glucose monitoring will be repeated at the end of study participation.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: canagliflozin
Subjects randomized to this arm will start with 100 mg tablet and increase to 300 mg tablet at Visit 4 if well tolerated.
Drug: canagliflozin
Subjects randomized to active drug will receive canagliflozin 100 mg . If study drug well tolerated, dose will be increased to 300 mg canagliflozin at Visit 4.
Other Names:
  • Invokana
Placebo Comparator: placebo
Subjects randomized to this arm will start with 100 mg tablet and increase to 300 mg tablet at Visit 4 if well tolerated.
Drug: placebo
Subjects randomized to placebo will receive 100 mg placebo pill . If study drug well tolerated, dose will be increased to 300 mg placebo pill at Visit 4.
Other Names:
  • inactive substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who discontinue all pre-meal medications for at least one meal per day
Time Frame: 24 weeks
24 weeks
Number of patients who replace mealtime insulin with an oral agent for at least one meal per day
Time Frame: 24 weeks
anti-hyperglycemic pill instead of insulin for at least one meal per day
24 weeks
Number of patients with a continuing need for insulin 4 times per day
Time Frame: 24 weeks
no change from the original basal -bolus regimen
24 weeks
Frequency and severity of hypoglycemia
Time Frame: 24 weeks
Hypoglycemic episodes will be evaluated using a hypoglycemia questionnaire
24 weeks
Self monitoring and continuous monitoring blood glucose levels
Time Frame: 24 weeks
glycemic control and glycemic variability
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Atlanta Veterans Education and Research, Inc.

Collaborators

Janssen Scientific Affairs, LLC

Investigators

  • Principal Investigator: Lawrence S Phillips, MD, Atlanta VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28431754DIA4008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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