The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Versus Sitagliptin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy
2 other identifiers
interventional
756
17 countries
184
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 diabetes-mellitus-type-2
Started Jul 2010
Typical duration for phase_3 diabetes-mellitus-type-2
184 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
June 3, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
May 17, 2013
CompletedJanuary 15, 2015
January 1, 2015
1.7 years
June 3, 2010
April 2, 2013
January 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c From Baseline to Week 52
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.
Day 1 (Baseline) and Week 52
Secondary Outcomes (6)
Percentage of Patients With HbA1c <7% at Week 52
Week 52
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52
Day 1 (Baseline) and Week 52
Percent Change in Body Weight From Baseline to Week 52
Day 1 (Baseline) and Week 52
Change in Systolic Blood Pressure (SBP) From Baseline to Week 52
Day 1 (Baseline) and Week 52
Percent Change in Triglycerides From Baseline to Week 52
Day 1 (Baseline) and Week 52
- +1 more secondary outcomes
Study Arms (2)
Canagliflozin 300 mg
EXPERIMENTALEach patient will receive 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Sitagliptin 100 mg
ACTIVE COMPARATOREach patient will receive 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Interventions
One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Eligibility Criteria
You may qualify if:
- All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea
- Patients in the study must have a HbA1c between \>=7 and \<=10.5% and a fasting plasma glucose (FPG) \<300 mg/dL (16.7 mmol/L)
You may not qualify if:
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- or a severe hypoglycemic episode within 6 months before screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (184)
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Mobile, Alabama, United States
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Goodyear, Arizona, United States
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Mesa, Arizona, United States
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Escondido, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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La Mesa, California, United States
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Laguna Hills, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Norwalk, California, United States
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Pismo Beach, California, United States
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Roseville, California, United States
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Spring Valley, California, United States
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Walnut Creek, California, United States
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Watsonville, California, United States
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Denver, Colorado, United States
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Northglenn, Colorado, United States
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Milford, Connecticut, United States
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Bradenton, Florida, United States
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Cape Coral, Florida, United States
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Clearwater, Florida, United States
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Delray Beach, Florida, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Lewiston, Idaho, United States
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Chicago, Illinois, United States
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O'Fallon, Illinois, United States
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Springfield, Illinois, United States
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Topeka, Kansas, United States
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Bowling Green, Kentucky, United States
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Lexington, Kentucky, United States
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Madisonville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Mandeville, Louisiana, United States
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Metairie, Louisiana, United States
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Sunset, Louisiana, United States
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Brockton, Massachusetts, United States
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Saint Clair Shores, Michigan, United States
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Southfield, Michigan, United States
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Dakota Dunes, Nebraska, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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West Seneca, New York, United States
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Calabash, North Carolina, United States
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Greensboro, North Carolina, United States
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Moerhead City, North Carolina, United States
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Morganton, North Carolina, United States
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Cincinnati, Ohio, United States
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Gallipolis, Ohio, United States
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Marion, Ohio, United States
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Mason, Ohio, United States
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Toledo, Ohio, United States
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Zanesville, Ohio, United States
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Beaver, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Perryopolis, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pottstown, Pennsylvania, United States
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Greenville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Johnson City, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Killeen, Texas, United States
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Richardson, Texas, United States
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San Antonio, Texas, United States
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Schertz, Texas, United States
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Sugar Land, Texas, United States
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Burke, Virginia, United States
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Danville, Virginia, United States
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Falls Church, Virginia, United States
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Hampton, Virginia, United States
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Henrico, Virginia, United States
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Manassas, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Selah, Washington, United States
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Tacoma, Washington, United States
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Salzburg, Austria
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Vienna, Austria
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Hedersem (Aalst), Belgium
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Tremelo, Belgium
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Belém, Brazil
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Brasília, Brazil
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Fortaleza, Brazil
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Goiânia, Brazil
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Marília, Brazil
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Calgary, Alberta, Canada
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Red Deer, Alberta, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Sherbrooke, Quebec, Canada
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Ville, Laint-Laurent, Quebec, Canada
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Pointe-Claire, Canada
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Toronto, Canada
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Aalborg, Denmark
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Ballerup Municipality, Denmark
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Gentofte Municipality, Denmark
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Vejle, Denmark
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Vipperoed, Denmark
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Bondy, France
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Dijon, France
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Marseille, France
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Nantes, France
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Narbonne, France
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Paris, France
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Pessac, France
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Saint-Etienne, France
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Berlin, Germany
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Dresden, Germany
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Eisenach, Germany
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Großheirath, Germany
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Meißen, Germany
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Bangalore, India
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Coimbatore, India
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Hyderabad, India
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Jaipur, India
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Nagpur, India
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Nashik, India
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Pune, India
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Beersheba, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Nazareth, Israel
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Rishon LeZiyyon, Israel
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Tel Aviv, Israel
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Ipoh, Malaysia
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Johor Bahru, Malaysia
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Kelantan, Malaysia
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Kuala Selangor, Malaysia
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Breda, Netherlands
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Eindhoven, Netherlands
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Groningen, Netherlands
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Leiderdorp, Netherlands
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Rotterdam, Netherlands
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Velp Gld, Netherlands
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Zoetermeer, Netherlands
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Christchurch, New Zealand
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Dunedin, New Zealand
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Rotorua, New Zealand
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Tauranga, New Zealand
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Wellington, New Zealand
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Bialystok, Poland
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Chrzanów, Poland
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Gdansk, Poland
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Kamieniec Ząbkowicki, Poland
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Krakow, Poland
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Lublin, Poland
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Sobótka, Poland
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Sopot, Poland
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Torun, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Singapore, Singapore
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Busan, South Korea
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Daegu, South Korea
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Jeonju, South Korea
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Seongnam, South Korea
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Seoul, South Korea
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Dnipro, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Sumy, Ukraine
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Ternopil, Ukraine
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Vinnitsa, Ukraine
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Zaporizhzhya, Ukraine
Related Publications (8)
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: 29313267DERIVEDQiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.
PMID: 27977934DERIVEDSchernthaner G, Lavalle-Gonzalez FJ, Davidson JA, Jodon H, Vijapurkar U, Qiu R, Canovatchel W. Canagliflozin provides greater attainment of both HbA1c and body weight reduction versus sitagliptin in patients with type 2 diabetes. Postgrad Med. 2016 Nov;128(8):725-730. doi: 10.1080/00325481.2016.1210988. Epub 2016 Jul 26.
PMID: 27391951DERIVEDWatts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.
PMID: 26580237DERIVEDLavalle-Gonzalez FJ, Eliaschewitz FG, Cerdas S, Chacon Mdel P, Tong C, Alba M. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from Latin America. Curr Med Res Opin. 2016;32(3):427-39. doi: 10.1185/03007995.2015.1121865. Epub 2016 Jan 14.
PMID: 26579834DERIVEDBailey RA, Vijapurkar U, Meininger G, Rupnow MF, Blonde L. Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials. Clin Ther. 2015 May 1;37(5):1045-54. doi: 10.1016/j.clinthera.2015.02.020. Epub 2015 Mar 18.
PMID: 25795432DERIVEDPolidori D, Mari A, Ferrannini E. Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves model-based indices of beta cell function in patients with type 2 diabetes. Diabetologia. 2014 May;57(5):891-901. doi: 10.1007/s00125-014-3196-x. Epub 2014 Mar 1.
PMID: 24585202DERIVEDSchernthaner G, Gross JL, Rosenstock J, Guarisco M, Fu M, Yee J, Kawaguchi M, Canovatchel W, Meininger G. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013 Sep;36(9):2508-15. doi: 10.2337/dc12-2491. Epub 2013 Apr 5.
PMID: 23564919DERIVED
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
Janssen Research & Development, LLC C. 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 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2010
First Posted
June 4, 2010
Study Start
July 1, 2010
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
January 15, 2015
Results First Posted
May 17, 2013
Record last verified: 2015-01