The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo 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: Canagliflozin Drug: Placebo Drug: Metformin Drug: Sulphonylruea |
| Phase | Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Responsible Party | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier | NCT01106625 |
| First Received | April 1, 2010 |
| Last Updated | June 12, 2013 |
| Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 1, 2010 |
|---|---|
| Last Updated Date | June 12, 2013 |
| Start Date | May 2010 |
| Estimated Primary Completion Date | April 2012 |
| Current Primary Outcome Measures | Change in HbA1c From Baseline to Week 26 [Time Frame: Day 1 (Baseline) and Week 26] [Designated as safety issue: No]The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea) |
|---|---|
| Official Title | A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 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 Sulphonylurea Therapy |
| Brief Summary | The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo 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), placebo-controlled, parallel-group, 3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients with T2DM who are not achieving an adequate response from current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes. Approximately 450 patients with T2DM who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control will receive once daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 52 weeks (includes 26 weeks of double-blind treatment followed by a 26-week extension period). In addition, all patients will take protocol-specified stable doses of metformin and sulphonylurea for the duration of the study. Patients will participate in the study for approximately 59 to 72 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with insulin (rescue therapy) consistent with local prescribing information. 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 (SMGB) measurements. The primary outcome measure in the study is to assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. All patients will take single-blind placebo capsules for 2 weeks before randomization. After randomization, patients will take double-blind canagliflozin (100 mg or 300 mg) or matching placebo 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: Canagliflozin One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Drug: Placebo One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Drug: Metformin The patient's stable dose of background metformin therapy should be continued throughout the study. Drug: Sulphonylruea The patient's stable dose of background sulphonylurea therapy should be continued throughout the study. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 469 |
| Estimated Completion Date | April 2012 |
| Estimated Primary Completion Date | September 2011 |
| 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% - Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 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, Australia, Belgium, Canada, France, Guatemala, Hungary, Israel, Mexico, Russian Federation, Spain, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01106625 |
|---|---|
| Other Study ID Numbers | CR017005 |
| Has Data Monitoring Committee | Yes |
| 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 | Huntsville, Alabama, United States |
|---|---|
| United States, Alaska | Little Rock, Alaska, United States |
| United States, Arizona | Phoenix, Arizona, United States |
| United States, California | Chino, California, United States |
| United States, California | Fair Oaks, California, United States |
| United States, California | Roseville, California, United States |
| United States, California | Wes Hills, California, United States |
| United States, Connecticut | Waterbury, Connecticut, United States |
| United States, Florida | Jacksonville, Florida, United States |
| United States, Florida | New Port Richey, Florida, United States |
| United States, Florida | Ocala, Florida, United States |
| United States, Florida | St Petersburg, Florida, United States |
| United States, Florida | West Palm Beach, Florida, United States |
| United States, Georgia | Augusta, Georgia, United States |
| United States, Georgia | Roswell, Georgia, United States |
| United States, Illinois | Chicago, Illinois, United States |
| United States, Kentucky | Lexington, Kentucky, United States |
| United States, Louisiana | New Orleans, Louisiana, United States |
| United States, Maryland | Reisterstown, Maryland, United States |
| United States, Mississippi | Olive Branch, Mississippi, United States |
| United States, Missouri | Saint Louis, Missouri, United States |
| United States, New York | Westfield, New York, United States |
| United States, North Carolina | Greenville, North Carolina, United States |
| United States, Ohio | Cincinnati, Ohio, United States |
| United States, Oklahoma | Tulsa, Oklahoma, United States |
| United States, Oregon | Medford, Oregon, United States |
| United States, Pennsylvania | Altoona, Pennsylvania, United States |
| United States, Pennsylvania | Harleysville, Pennsylvania, United States |
| United States, Pennsylvania | Levittown, Pennsylvania, United States |
| United States, Pennsylvania | Sellersville, Pennsylvania, United States |
| United States, South Carolina | Greer, South Carolina, United States |
| United States, Texas | Bryan, Texas, United States |
| United States, Texas | Dallas, Texas, United States |
| United States, Texas | Desoto, Texas, United States |
| United States, Utah | Salt Lake City, Utah, United States |
| United States, Vermont | South Burlington, Vermont, United States |
| United States, Washington | Wenatchee, Washington, United States |
| Australia | Freemantle, Australia |
| Australia | Heidelberg Heights, Australia |
| Australia | Meadowbrook, Australia |
| Australia | Nedlands, Australia |
| Australia | Wollongong, Australia |
| Belgium | Aalst, Belgium |
| Belgium | Bonheiden, Belgium |
| Belgium | Edegem, Belgium |
| Belgium | Leuven, Belgium |
| France | Corbeil Essonnes, France |
| France | La Rochelle, France |
| France | Le Creusot, France |
| France | Poitiers, France |
| France | Venissieux, France |
| Guatemala | Guatemala, Guatemala |
| Hungary | Balatonfured, Hungary |
| Hungary | Budapest, Hungary |
| Hungary | Győr, Hungary |
| Hungary | Zalaegerszeg, Hungary |
| Israel | Haifa, Israel |
| Israel | Holon, Israel |
| Israel | Jerusalem, Israel |
| Israel | Tel Aviv, Israel |
| Mexico | Guadalajara, Mexico |
| Mexico | Monterrey, Mexico |
| Puerto Rico | Carolina, Puerto Rico |
| Puerto Rico | Trujillo Alto, Puerto Rico |
| Russian Federation | Arkhangelsk, Russian Federation |
| Russian Federation | Saint Petersburg, Russian Federation |
| Russian Federation | Samara, Russian Federation |
| Spain | Alicante, Spain |
| Spain | Almeria, Spain |
| Spain | Malaga, Spain |
| Spain | Sevilla, Spain |
| Spain | Valencia, Spain |
| United Kingdom | Belfast, United Kingdom |
| United Kingdom | Bolton, United Kingdom |
| United Kingdom | Liverpool, United Kingdom |
| United Kingdom | Manchester, United Kingdom |