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Diabetes Mellitus, Type 1Phase 2NCT02139943

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

A Phase 2 study testing Canagliflozin 100 mg and Canagliflozin 300 mg in people with Diabetes Mellitus, Type 1, run by Janssen Research & Development, LLC at 53 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Canagliflozin 100 mg and Canagliflozin 300 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
352 participants
Where
53 sitesin 2 countries
Study dates
May 2014to Jun 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

53 sites in 2 countries.

53 sites in 2 countries

United States46 sites

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Billings, Montana

  • Study site

    Billings, New York

  • Study site

    Bloomington, Tennessee

  • Study site

    Columbus, Ohio

  • Study site

    Concord, California

  • Study site

    Council Bluffs, Iowa

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Des Moines, Iowa

  • Study site

    El Paso, Nevada

  • Study site

    El Paso, Texas

  • Study site

    Greer, South Carolina

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Los Gatos, California

  • Study site

    Mentor, Ohio

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Morehead City, North Carolina

  • Study site

    Nashua, New Hampshire

  • Study site

    Northridge, California

  • Study site

    Ogden, Utah

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Palm Harbor, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Rockville, Maryland

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    Schertz, Texas

  • Study site

    Smithtown, New York

  • Study site

    Spokane, Washington

  • Study site

    Temecula, California

  • Study site

    Tomball, Texas

  • Study site

    Tustin, California

  • Study site

    Ventura, California

  • Study site

    Walnut Creek, California

Other trials in United States

Canada7 sites

  • Study site

    Calgary, Alberta

  • Study site

    Laval, Quebec

  • Study site

    London, Ontario

  • Study site

    Oakville, Ontario

  • Study site

    Sainte-Foy, Quebec

  • Study site

    Thornhill, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

About this study

Official title: 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).

Read the 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.

Being tested
Canagliflozin 100 mg, Canagliflozin 300 mg, Placebo
Keywords
Diabetes Mellitus, Type 1, Canagliflozin, Continuous Glucose Monitoring
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Canagliflozin 100 mgDrug

    Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.

  • Canagliflozin 300 mgDrug

    Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.

  • PlaceboDrug

    Matching placebo capsule will be taken orally, before the first meal of the day.

Study groups in NCT02139943
Study groupRoleWhat they receive
Canagliflozin 100 mgExperimentalEach participant will receive 100 mg of canagliflozin once daily for 18 weeks.
Receives: Drug: Canagliflozin 100 mg
Canagliflozin 300 mgExperimentalEach participant will receive 300 mg of canagliflozin once daily for 18 weeks.
Receives: Drug: Canagliflozin 300 mg
PlaceboPlacebo comparatorEach participant will receive matching placebo once daily for 18 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight

    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.

    Measured: Week 18

  2. Percentage of Participants With Adverse Events

    Measured: Up to 22 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02139943
Sponsor's protocol ID
CR104173
Other IDs
2013-005078-24, 28431754DIA2004
Status last verified
Jun 2016
First submitted
14 May 2014
Last updated
18 Jul 2016
Data monitoring committee
Yes

Publications

  • Rodbard HW, Peters AL, Slee A, Cao A, Traina SB, Alba M. The Effect of Canagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, on Glycemic End Points Assessed by Continuous Glucose Monitoring and Patient-Reported Outcomes Among People With Type 1 Diabetes. Diabetes Care. 2017 Feb;40(2):171-180. doi: 10.2337/dc16-1353. Epub 2016 Nov 29.

    PubMed 27899497

  • Peters AL, Henry RR, Thakkar P, Tong C, Alba M. Diabetic Ketoacidosis With Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, in Patients With Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):532-8. doi: 10.2337/dc15-1995.

    PubMed 26989182

  • Henry RR, Thakkar P, Tong C, Polidori D, Alba M. Efficacy and Safety of Canagliflozin, a Sodium-Glucose Cotransporter 2 Inhibitor, as Add-on to Insulin in Patients With Type 1 Diabetes. Diabetes Care. 2015 Dec;38(12):2258-65. doi: 10.2337/dc15-1730. Epub 2015 Oct 20.

    PubMed 26486192

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Canagliflozin 100 mg and Canagliflozin 300 mg in people with Diabetes Mellitus, Type 1, run by Janssen Research & Development, LLC at 53 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02139943, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.

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