An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Parallel Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered SGLT2 Inhibitor JNJ-28431754 With Sitagliptin as a Reference Arm
2 other identifiers
interventional
451
13 countries
78
Brief Summary
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2008
Shorter than P25 for phase_2
78 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
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
May 17, 2013
CompletedJuly 19, 2013
July 1, 2013
9 months
March 21, 2008
April 1, 2013
July 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to Week 12
The table below shows the mean change in HbA1c from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the least-squares mean change.
Day 1 (Baseline) and Week 12
Secondary Outcomes (5)
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12
Day 1 (Baseline) and Week 12
Percentage of Patients With Symptoms of Hypoglycemia
Up to Week 12
Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12
Day 1 (Baseline) and Week 12
Absolute Change in Body Weight From Baseline to Week 12
Day 1 (Baseline) and Week 12
Percent Change in Body Weight From Baseline to Week 12
Day 1 (Baseline) and Week 12
Study Arms (7)
Canagliflozin 50 mg daily
EXPERIMENTALEach patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 100 mg daily
EXPERIMENTALEach patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 200 mg daily
EXPERIMENTALEach patient will receive 200 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Canagliflozin 300 mg daily
EXPERIMENTALEach patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily (in the morning) for 12 weeks with matching placebo capsule once daily (in the evening).
Canagliflozin 300 mg twice daily
EXPERIMENTALEach patient will receive 300 mg of canagliflozin (JNJ-28431754) twice daily for 12 weeks.
Sitagliptin 100 mg daily
ACTIVE COMPARATOREach patient will receive 100 mg of sitagliptin once daily (in the morning) for 12 weeks with matching placebo once daily (in the evening).
Placebo
PLACEBO COMPARATOREach patient will receive matching placebo twice daily for 12 weeks.
Interventions
One 50 mg, 100 mg, 200 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks or one 300 mg over-encapsulated tablet orally twice daily for 12 weeks.
One 100 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
One matching placebo capsule orally (by mouth) once or twice daily for 12 weeks.
Eligibility Criteria
You may qualify if:
- Patients must have a diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c levels \>=7% and \<=10.5%
- taking a stable daily dose of metformin
- Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
- Stable body weight
- Serum creatinine \<=1.5 mg/dL (132.6 umol/L) for men and \<=1.4 mg/dL (123.76 umol/L) for women
You may not qualify if:
- Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
- Known contraindication or suspected hypersensitivity to sitagliptin or metformin
- A history of diabetic ketoacidosis or type 1 diabetes mellitus
- History of pancreas or beta-cell transplantation
- History of active proliferative diabetic retinopathy
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
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Birmingham, Alabama, United States
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Mesa, Arizona, United States
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Tucson, Arizona, United States
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Encinitas, California, United States
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Lincoln, California, United States
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Los Angeles, California, United States
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Merced, California, United States
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Roseville, California, United States
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Denver, Colorado, United States
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Golden, Colorado, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Boise, Idaho, United States
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Nampa, Idaho, United States
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Topeka, Kansas, United States
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Haverhill, Massachusetts, United States
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Cherry Hill, New Jersey, United States
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Albuquerque, New Mexico, United States
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New Hyde Park, New York, United States
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Salisbury, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Greer, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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New Braunfels, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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Bueos Aires, Argentina
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Pleven, Bulgaria
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Sofia, Bulgaria
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Chilliwack, British Columbia, Canada
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Coquitlam, British Columbia, Canada
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Brampton, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Saint Romuald, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Olomouc, Czechia
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Písek, Czechia
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Prague, Czechia
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Bangalore, India
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Hyderabad, India
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Nagpur, India
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Pune, India
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Kota Bharu, Malaysia
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Kuala Lumpur, Malaysia
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Mexico City, Mexico
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México, Mexico
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Monterrey, Mexico
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Zapopan, Mexico
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Bydgoszcz, Poland
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Gdansk, Poland
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Kutno, Poland
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Lodz, Poland
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Lublin, Poland
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Torun, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Ponce Pr, Puerto Rico
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San Juan, Puerto Rico
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Baia Mare, Romania
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Brasov, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Galati, Romania
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Ploieşti, Romania
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Moscow, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Belfast, United Kingdom
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Bolton, United Kingdom
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Exeter, United Kingdom
Unknown Facility
Lincoln, United Kingdom
Related Publications (3)
Nyirjesy P, Zhao Y, Ways K, Usiskin K. Evaluation of vulvovaginal symptoms and Candida colonization in women with type 2 diabetes mellitus treated with canagliflozin, a sodium glucose co-transporter 2 inhibitor. Curr Med Res Opin. 2012 Jul;28(7):1173-8. doi: 10.1185/03007995.2012.697053. Epub 2012 Jun 14.
PMID: 22632452DERIVEDNicolle LE, Capuano G, Ways K, Usiskin K. Effect of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on bacteriuria and urinary tract infection in subjects with type 2 diabetes enrolled in a 12-week, phase 2 study. Curr Med Res Opin. 2012 Jul;28(7):1167-71. doi: 10.1185/03007995.2012.689956. Epub 2012 May 15.
PMID: 22548646DERIVEDRosenstock J, Aggarwal N, Polidori D, Zhao Y, Arbit D, Usiskin K, Capuano G, Canovatchel W; Canagliflozin DIA 2001 Study Group. Dose-ranging effects of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, as add-on to metformin in subjects with type 2 diabetes. Diabetes Care. 2012 Jun;35(6):1232-8. doi: 10.2337/dc11-1926. Epub 2012 Apr 9.
PMID: 22492586DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
March 21, 2008
First Posted
March 25, 2008
Study Start
April 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
July 19, 2013
Results First Posted
May 17, 2013
Record last verified: 2013-07