A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
NCT ID: NCT02139943
Last Updated: 2016-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
352 participants
INTERVENTIONAL
2014-05-31
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks.
Canagliflozin 100 mg
Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
Canagliflozin 300 mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks.
Canagliflozin 300 mg
Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
Placebo
Each participant will receive matching placebo once daily for 18 weeks
Placebo
Matching placebo capsule will be taken orally, before the first meal of the day.
Interventions
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Canagliflozin 100 mg
Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
Canagliflozin 300 mg
Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
Placebo
Matching placebo capsule will be taken orally, before the first meal of the day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
65 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Little Rock, Arkansas, United States
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
Denver, Colorado, United States
Miami, Florida, United States
Palm Harbor, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Council Bluffs, Iowa, United States
Des Moines, Iowa, United States
Baton Rouge, Louisiana, United States
Rockville, Maryland, United States
Billings, Montana, United States
Omaha, Nebraska, United States
El Paso, Nevada, United States
Las Vegas, Nevada, United States
Nashua, New Hampshire, United States
Billings, New York, United States
Smithtown, New York, United States
Morehead City, North Carolina, United States
Columbus, Ohio, United States
Mentor, Ohio, United States
Philadelphia, Pennsylvania, United States
Greer, South Carolina, United States
Bloomington, Tennessee, United States
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
Ogden, Utah, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
London, Ontario, Canada
Oakville, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Laval, Quebec, Canada
Sainte-Foy, Quebec, Canada
Countries
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References
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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.
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.
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.
Other Identifiers
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2013-005078-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
28431754DIA2004
Identifier Type: OTHER
Identifier Source: secondary_id
CR104173
Identifier Type: -
Identifier Source: org_study_id
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