A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
NCT ID: NCT02025907
Last Updated: 2016-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
218 participants
INTERVENTIONAL
2014-02-28
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Canagliflozin (JNJ-28431754)
Each participant will receive canagliflozin (JNJ-28431754) 100 mg once daily during the first 6 weeks, then the dose may be increased to 300 mg once daily.
Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily.
Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily.
Placebo
Each participant will receive placebo (inactive medication) once daily for 28 weeks.
Placebo
One placebo capsule taken orally (by mouth) once daily.
Interventions
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Canagliflozin, 100 mg
One 100 mg capsule taken orally (by mouth) once daily.
Canagliflozin, 300 mg
One 300 mg capsule taken orally (by mouth) once daily.
Placebo
One placebo capsule taken orally (by mouth) once daily.
Eligibility Criteria
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Inclusion Criteria
* Must have a screening HbA1c of \>=7.5% to \<=10.5%
* Must be on metformin \>=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening
Exclusion Criteria
* A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
* eGFR \<60 ml/min/1.73m2, or serum creatinine \>=1.4 mg/dL for men and \>=1.3 mg/dL for women
* Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
* Major surgery (ie, requiring general anesthesia) within 12 weeks before screening
18 Years
75 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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Montgomery, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Northridge, California, United States
Norwalk, California, United States
Rancho Cucamonga, California, United States
San Ramon, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Littleton, Colorado, United States
Cooper City, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Atlanta, Georgia, United States
Perry, Georgia, United States
Shawnee Mission, Kansas, United States
Marrero, Louisiana, United States
Metairie, Louisiana, United States
Metarie, Louisiana, United States
Rockville, Maryland, United States
Jackson, Mississippi, United States
Picayune, Mississippi, United States
St Louis, Missouri, United States
Nashua, New Hampshire, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Arlington, Texas, United States
San Antonio, Texas, United States
Sugarland, Texas, United States
Bountiful, Utah, United States
Coffs Harbour, , Australia
Freemantle, , Australia
Geelong, , Australia
Heidelberg, , Australia
Herston, , Australia
Melbourne, , Australia
Merewether, , Australia
Sherwood, , Australia
Sydney, , Australia
Wollongong, , Australia
Brampton, Ontario, Canada
Hawkesbury, Ontario, Canada
Toronto, Ontario, Canada
La Rochelle Cedex 1 Poitou-Cha, , France
La Tronche, , France
Nancy, , France
Narbonne, , France
Nice, , France
Paris, , France
Vénissieux, , France
Freiburg im Breisgau, , Germany
Fulda, , Germany
Hamburg, , Germany
Münster, , Germany
Neuwied, , Germany
Pirna, , Germany
Speyer, , Germany
Countries
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References
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Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.
Other Identifiers
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2013-004819-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
28431754DIA4004
Identifier Type: OTHER
Identifier Source: secondary_id
CR103477
Identifier Type: -
Identifier Source: org_study_id