A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)

June 7, 2016 updated by: Janssen Research & Development, LLC

A Randomized Phase 2, Double-blind, Placebo-controlled, Treat-to-Target, Parallel-group, 3-arm, Multicenter Study to Assess the Efficacy and Safety of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Subjects With Type 1 Diabetes Mellitus

The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin therapy for participants with type 1 diabetes mellitus and inadequate glycemic control.

Approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. About 90 participants (30 per treatment group) will be selected for a substudy with a purpose of a continuous glucose monitoring (CGM) assessment for 7 days at baseline and 7 days at the end of treatment.

The total duration of the participation will be about 22 weeks, during which participants will need to return to investigational sites for approximately 9 visits. During the study participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis (DKA), as well as on compliance with diet and exercise.

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 2

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • London, Ontario, Canada
      • Oakville, Ontario, Canada
      • Thornhill, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Laval, Quebec, Canada
      • Sainte-Foy, Quebec, Canada
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Concord, California, United States
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Los Gatos, California, United States
      • Northridge, California, United States
      • Orange, California, United States
      • San Francisco, California, United States
      • Temecula, California, United States
      • Tustin, California, United States
      • Ventura, California, United States
      • Walnut Creek, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • Palm Harbor, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Iowa
      • Council Bluffs, Iowa, United States
      • Des Moines, Iowa, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Rockville, Maryland, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • El Paso, Nevada, United States
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New York
      • Billings, New York, United States
      • Smithtown, New York, United States
    • North Carolina
      • Morehead City, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
      • Mentor, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Greer, South Carolina, United States
    • Tennessee
      • Bloomington, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • El Paso, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
      • Schertz, Texas, United States
      • Tomball, Texas, United States
    • Utah
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
    • Washington
      • Spokane, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

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

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have type 1 diabetes mellitus (T1DM) for at least 1 year
  • Must have have inadequate glycemic control (as defined by glycosylated hemoglobin level of >= 7.0% to <= 9.0%) on basal plus bolus insulin at screening
  • Must have body mass index 21 to 35 kg/m2 inclusive
  • Must be on a total daily dose of insulin >= 0.6 IU/kg at screening
  • Must be on a stable insulin regimen for at least 8 weeks prior to screening

Exclusion Criteria:

  • History of T2DM, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • Severe hypoglycemia (defined as an event required assistance from another person, or which resulted in seizure or loss of consciousness) within 6 months prior to study start
  • Diabetic ketoacidosis within 6 months prior to study start
  • History of hereditary glucose-galactose malabsorption or primary renal glycosuria
  • An ongoing, inadequately controlled thyroid disorder

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
Experimental: Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks.
Drug: Canagliflozin 100 mg
Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
Experimental: Canagliflozin 300 mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks.
Drug: Canagliflozin 300 mg
Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
Placebo Comparator: Placebo
Each participant will receive matching placebo once daily for 18 weeks
Drug: Placebo
Matching placebo capsule will be taken orally, before the first meal of the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight
Time Frame: Week 18
Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.
Week 18
Percentage of Participants With Adverse Events
Time Frame: Up to 22 Weeks
Up to 22 Weeks

Collaborators and Investigators

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

Sponsor

Janssen Research & Development, LLC

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

May 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR104173
  • 2013-005078-24 (EudraCT Number)
  • 28431754DIA2004 (Other Identifier: Janssen Research & Development, LLC)

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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