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
A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy
3 other identifiers
interventional
218
5 countries
57
Brief Summary
The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Feb 2014
57 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
First Submitted
Initial submission to the registry
December 30, 2013
CompletedFirst Posted
Study publicly available on registry
January 1, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
September 2, 2016
CompletedOctober 31, 2016
October 1, 2016
1.6 years
December 30, 2013
July 22, 2016
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Baseline and Week 26
Secondary Outcomes (4)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Baseline and Week 26
Percent Change From Baseline in Body Weight at Week 26
Baseline and Week 26
Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26
Week 26
Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Baseline and Week 26
Study Arms (2)
Canagliflozin (JNJ-28431754)
EXPERIMENTALEach 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.
Placebo
PLACEBO COMPARATOREach participant will receive placebo (inactive medication) once daily for 28 weeks.
Interventions
One 100 mg capsule taken orally (by mouth) once daily.
One 300 mg capsule taken orally (by mouth) once daily.
Eligibility Criteria
You may qualify if:
- Must have a diagnosis of type 2 diabetes mellitus
- 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
You may not qualify if:
- History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Unknown Facility
Montgomery, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Northridge, California, United States
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Norwalk, California, United States
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Rancho Cucamonga, California, United States
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San Ramon, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Cooper City, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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Atlanta, Georgia, United States
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Perry, Georgia, United States
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Shawnee Mission, Kansas, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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Metarie, Louisiana, United States
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Rockville, Maryland, United States
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Jackson, Mississippi, United States
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Picayune, Mississippi, United States
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St Louis, Missouri, United States
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Nashua, New Hampshire, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Arlington, Texas, United States
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San Antonio, Texas, United States
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Sugarland, Texas, United States
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Bountiful, Utah, United States
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Coffs Harbour, Australia
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Freemantle, Australia
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Geelong, Australia
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Heidelberg, Australia
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Herston, Australia
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Melbourne, Australia
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Merewether, Australia
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Sherwood, Australia
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Sydney, Australia
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Wollongong, Australia
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Brampton, Ontario, Canada
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Hawkesbury, Ontario, Canada
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Toronto, Ontario, Canada
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La Rochelle Cedex 1 Poitou-Cha, France
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La Tronche, France
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Nancy, France
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Narbonne, France
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Nice, France
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Paris, France
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Vénissieux, France
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Freiburg im Breisgau, Germany
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Fulda, Germany
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Hamburg, Germany
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Münster, Germany
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Neuwied, Germany
Unknown Facility
Pirna, Germany
Unknown Facility
Speyer, Germany
Related Publications (1)
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.
PMID: 29313267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Leader
- 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 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2013
First Posted
January 1, 2014
Study Start
February 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 31, 2016
Results First Posted
September 2, 2016
Record last verified: 2016-10