The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Sitagliptin 100 mg Drug: Canagliflozin 300 mg Drug: Metformin Drug: Sulphonylurea |
| Phase | Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Responsible Party | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier | NCT01137812 |
| First Received | June 3, 2010 |
| Last Updated | June 13, 2013 |
| Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 3, 2010 |
|---|---|
| Last Updated Date | June 13, 2013 |
| Start Date | July 2010 |
| Estimated Primary Completion Date | March 2012 |
| Current Primary Outcome Measures | Change in HbA1c From Baseline to Week 52 [Time Frame: Day 1 (Baseline) and Week 52] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial) |
|---|---|
| Official Title | 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 |
| 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. |
| Detailed Description | Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), multicenter study to determine the efficacy, safety, and tolerability of canagliflozin 300 mg compared to sitagliptin 100 mg (an antihyperglycemic drug) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes. Approximately 720 patients with T2DM who are receiving combination therapy with metformin and sulphonylurea will receive the addition of once-daily treatment with canagliflozin 300 mg or sitagliptin 100 mg capsules for 52 weeks. Patients will participate in the study for approximately 59 to 72 weeks. During treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ECGs), vital signs measurements, body weight, physical examinations, and self monitored blood glucose (SMBG) measurements. The primary outcome measure in the study is the effect of canagliflozin compared to sitagliptin on hemoglobin A1c (HbA1c) after 52 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single-blind placebo for 2 weeks before randomization. After randomization, patients in the study will take double-blind canagliflozin 300 mg or matching sitagliptin 100 mg for 52 weeks. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Sitagliptin 100 mg One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea Drug: Canagliflozin 300 mg One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea Drug: Metformin 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. Drug: Sulphonylurea 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. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 756 |
| Estimated Completion Date | March 2012 |
| Estimated Primary Completion Date | March 2012 |
| Eligibility Criteria | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, India, Israel, Korea, Republic of, Malaysia, Netherlands, New Zealand, Poland, Singapore, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01137812 |
|---|---|
| Other Study ID Numbers | CR017185 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Janssen Research & Development, LLC |
| Study Sponsor | Janssen Research & Development, LLC |
| Collaborators | Not Provided |
| Investigators | Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC |
| Verification Date | June 2013 |
Locations[ + expand ][ + ]
| United States, Alabama | Mobile, Alabama, United States |
|---|---|
| United States, Arizona | Goodyear, Arizona, United States |
| United States, Arizona | Mesa, Arizona, United States |
| United States, California | Escondido, California, United States |
| United States, California | Fresno, California, United States |
| United States, California | Greenbrae, California, United States |
| United States, California | La Mesa, California, United States |
| United States, California | Laguna Hills, California, United States |
| United States, California | Lancaster, California, United States |
| United States, California | Long Beach, California, United States |
| United States, California | Los Angeles, California, United States |
| United States, California | Norwalk, California, United States |
| United States, California | Pismo Beach, California, United States |
| United States, California | Roseville, California, United States |
| United States, California | Spring Valley, California, United States |
| United States, California | Walnut Creek, California, United States |
| United States, California | Watsonville, California, United States |
| United States, Colorado | Denver, Colorado, United States |
| United States, Colorado | Northglenn, Colorado, United States |
| United States, Connecticut | Milford, Connecticut, United States |
| United States, Florida | Bradenton, Florida, United States |
| United States, Florida | Cape Coral, Florida, United States |
| United States, Florida | Clearwater, Florida, United States |
| United States, Florida | Delray Beach, Florida, United States |
| United States, Florida | Miami, Florida, United States |
| United States, Florida | Pembroke Pines, Florida, United States |
| United States, Florida | Tampa, Florida, United States |
| United States, Georgia | Atlanta, Georgia, United States |
| United States, Idaho | Lewiston, Idaho, United States |
| United States, Illinois | Chicago, Illinois, United States |
| United States, Illinois | O'Fallon, Illinois, United States |
| United States, Illinois | Springfield, Illinois, United States |
| United States, Kansas | Topeka, Kansas, United States |
| United States, Kentucky | Bowling Green, Kentucky, United States |
| United States, Kentucky | Lexington, Kentucky, United States |
| United States, Kentucky | Madisonville, Kentucky, United States |
| United States, Louisiana | Baton Rouge, Louisiana, United States |
| United States, Louisiana | Mandeville, Louisiana, United States |
| United States, Louisiana | Metairie, Louisiana, United States |
| United States, Louisiana | Sunset, Louisiana, United States |
| United States, Massachusetts | Brockton, Massachusetts, United States |
| United States, Michigan | Saint Clair Shores, Michigan, United States |
| United States, Michigan | Southfield, Michigan, United States |
| United States, Nebraska | Dakota Dunes, Nebraska, United States |
| United States, New Jersey | Toms River, New Jersey, United States |
| United States, New Mexico | Albuquerque, New Mexico, United States |
| United States, New York | West Seneca, New York, United States |
| United States, North Carolina | Calabash, North Carolina, United States |
| United States, North Carolina | Greensboro, North Carolina, United States |
| United States, North Carolina | Moerhead City, North Carolina, United States |
| United States, North Carolina | Morganton, North Carolina, United States |
| United States, Ohio | Cincinnati, Ohio, United States |
| United States, Ohio | Gallipolis, Ohio, United States |
| United States, Ohio | Marion, Ohio, United States |
| United States, Ohio | Mason, Ohio, United States |
| United States, Ohio | Toledo, Ohio, United States |
| United States, Ohio | Zanesville, Ohio, United States |
| United States, Pennsylvania | Beaver, Pennsylvania, United States |
| United States, Pennsylvania | Bensalem, Pennsylvania, United States |
| United States, Pennsylvania | Norristown, Pennsylvania, United States |
| United States, Pennsylvania | Perryopolis, Pennsylvania, United States |
| United States, Pennsylvania | Philadelphia, Pennsylvania, United States |
| United States, Pennsylvania | Pittsburgh, Pennsylvania, United States |
| United States, Pennsylvania | Pottstown, Pennsylvania, United States |
| United States, South Carolina | Greenville, South Carolina, United States |
| United States, South Carolina | Spartanburg, South Carolina, United States |
| United States, Tennessee | Johnson City, Tennessee, United States |
| United States, Texas | Dallas, Texas, United States |
| United States, Texas | Fort Worth, Texas, United States |
| United States, Texas | Killeen, Texas, United States |
| United States, Texas | Richardson, Texas, United States |
| United States, Texas | San Antonio, Texas, United States |
| United States, Texas | Schertz, Texas, United States |
| United States, Texas | Sugar Land, Texas, United States |
| United States, Virginia | Burke, Virginia, United States |
| United States, Virginia | Danville, Virginia, United States |
| United States, Virginia | Falls Church, Virginia, United States |
| United States, Virginia | Hampton, Virginia, United States |
| United States, Virginia | Henrico, Virginia, United States |
| United States, Virginia | Manassas, Virginia, United States |
| United States, Virginia | Norfolk, Virginia, United States |
| United States, Virginia | Richmond, Virginia, United States |
| United States, Washington | Selah, Washington, United States |
| United States, Washington | Tacoma, Washington, United States |
| Austria | Salzburg, Austria |
| Austria | Wien, Austria |
| Belgium | Hedersem (Aalst), Belgium |
| Belgium | Tremelo, Belgium |
| Brazil | Belem, Brazil |
| Brazil | Brasilia, Brazil |
| Brazil | Fortaleza, Brazil |
| Brazil | Goiânia, Brazil |
| Brazil | Marília, Brazil |
| Brazil | Passo Fundo, Brazil |
| Brazil | Porto Alegre, Brazil |
| Brazil | Sao Paulo, Brazil |
| Canada, Alberta | Red Deer, Alberta, Canada |
| Canada, British Columbia | Vancouver, British Columbia, Canada |
| Canada, Nova Scotia | Halifax, Nova Scotia, Canada |
| Canada, Ontario | Brampton, Ontario, Canada |
| Canada, Ontario | Oshawa, Ontario, Canada |
| Canada, Prince Edward Island | Charlottetown, Prince Edward Island, Canada |
| Canada, Quebec | Sherbrooke, Quebec, Canada |
| Canada, Quebec | Ville, Laint-Laurent, Quebec, Canada |
| Canada | Calgary, Canada |
| Canada | Hamilton, Canada |
| Canada | Pointe-Claire, Canada |
| Canada | Toronto, Canada |
| Denmark | Ballerup, Denmark |
| Denmark | Gentofte, Denmark |
| Denmark | Roskilde, Denmark |
| Denmark | Vejle, Denmark |
| Denmark | Vipperoed, Denmark |
| France | Bondy Cedex, France |
| France | Dijon, France |
| France | Marseille, France |
| France | Nantes, France |
| France | Narbonne Cedex, France |
| France | Paris, France |
| France | Pessac N/A, France |
| France | St Etienne, France |
| Germany | Berlin, Germany |
| Germany | Dresden, Germany |
| Germany | Eisenach, Germany |
| Germany | Großheirath, Germany |
| Germany | Meißen, Germany |
| India | Bangalore, India |
| India | Coimbatore, India |
| India | Hyderabad, India |
| India | Jaipur, India |
| India | Nagpur, India |
| India | Nashik, India |
| India | Pune, India |
| Israel | Beer Sheba, Israel |
| Israel | Jerusalem, Israel |
| Israel | Kfar Saba, Israel |
| Israel | Nazareth, Israel |
| Israel | Rishon Lezion, Israel |
| Israel | Tel-Aviv, Israel |
| Korea, Republic of | Busan, Korea, Republic of |
| Korea, Republic of | Daegu, Korea, Republic of |
| Korea, Republic of | Jeonju-Si, Korea, Republic of |
| Korea, Republic of | Seognam-Si, Kyungki-Do, Korea, Republic of |
| Korea, Republic of | Seoul, Korea, Republic of |
| Korea, Republic of | Sungnam Kyungki, Korea, Republic of |
| Malaysia | Ipoh, Malaysia |
| Malaysia | Johor Bahru, Malaysia |
| Malaysia | Kelantan, Malaysia |
| Malaysia | Selangor, Malaysia |
| Netherlands | Breda, Netherlands |
| Netherlands | Eindhoven, Netherlands |
| Netherlands | Groningen, Netherlands |
| Netherlands | Leiderdorp, Netherlands |
| Netherlands | Rotterdam, Netherlands |
| Netherlands | Velp Gld, Netherlands |
| Netherlands | Zoetermeer, Netherlands |
| New Zealand | Christchurch, New Zealand |
| New Zealand | Dunedin, New Zealand |
| New Zealand | Rotorua, New Zealand |
| New Zealand | Tauranga, New Zealand |
| New Zealand | Wellington, New Zealand |
| Poland | Bialystok, Poland |
| Poland | Chrzanow, Poland |
| Poland | Kamieniec Zabkowicki, Poland |
| Poland | Krakow, Poland |
| Poland | Lublin, Poland |
| Poland | Sobotka, Poland |
| Poland | Sopot, Poland |
| Poland | Torun, Poland |
| Poland | Wroclaw, Poland |
| Poland | Zabrze, Poland |
| Singapore | Singapore, Singapore |
| Ukraine | Dnepropetrovsk, Ukraine |
| Ukraine | Ivano Frankivsk, Ukraine |
| Ukraine | Kharkov, Ukraine |
| Ukraine | Kiev, Ukraine |
| Ukraine | Odessa, Ukraine |
| Ukraine | Poltava, Ukraine |
| Ukraine | Sumy, Ukraine |
| Ukraine | Ternopil, Ukraine |
| Ukraine | Vinnitsa, Ukraine |
| Ukraine | Zaporozhye, Ukraine |