A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
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
3 other identifiers
interventional
352
2 countries
53
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2014
Shorter than P25 for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 14, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
July 18, 2016
CompletedJuly 18, 2016
June 1, 2016
1.1 years
May 14, 2014
June 7, 2016
June 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Week 18
Percentage of Participants With Adverse Events
Up to 22 Weeks
Study Arms (3)
Canagliflozin 100 mg
EXPERIMENTALEach participant will receive 100 mg of canagliflozin once daily for 18 weeks.
Canagliflozin 300 mg
EXPERIMENTALEach participant will receive 300 mg of canagliflozin once daily for 18 weeks.
Placebo
PLACEBO COMPARATOREach participant will receive matching placebo once daily for 18 weeks
Interventions
Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Concord, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Angeles, California, United States
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Los Gatos, California, United States
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Northridge, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Temecula, California, United States
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Tustin, California, United States
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Ventura, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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Miami, Florida, United States
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Palm Harbor, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Council Bluffs, Iowa, United States
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Des Moines, Iowa, United States
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Baton Rouge, Louisiana, United States
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Rockville, Maryland, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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El Paso, Nevada, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Billings, New York, United States
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Smithtown, New York, United States
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Morehead City, North Carolina, United States
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Columbus, Ohio, United States
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Mentor, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Greer, South Carolina, United States
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Bloomington, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Schertz, Texas, United States
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Tomball, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
Unknown Facility
Calgary, Alberta, Canada
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London, Ontario, Canada
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Oakville, Ontario, Canada
Unknown Facility
Thornhill, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Laval, Quebec, Canada
Unknown Facility
Sainte-Foy, Quebec, Canada
Related Publications (3)
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.
PMID: 27899497DERIVEDPeters 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.
PMID: 26989182DERIVEDHenry 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.
PMID: 26486192DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Research
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2014
First Posted
May 16, 2014
Study Start
May 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 18, 2016
Results First Posted
July 18, 2016
Record last verified: 2016-06