The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)
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 receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Placebo Drug: Canagliflozin Drug: Sitagliptin Drug: Metformin Drug: Pioglitazone |
| Phase | Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Responsible Party | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier | NCT01106690 |
| First Received | April 1, 2010 |
| Last Updated | June 26, 2013 |
| Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 1, 2010 |
|---|---|
| Last Updated Date | June 26, 2013 |
| Start Date | June 2010 |
| Estimated Primary Completion Date | July 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-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone) |
|---|---|
| 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 Pioglitazone 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 receving treatment with metformin and pioglitazone 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), 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 pioglitazone to control their diabetes. Approximately 360 patients with T2DM who are receiving combination therapy with metformin and pioglitazone will receive the addition of once-daily treatment with canagliflozin (100 mg or 300 mg) or placebo capsules for 26 weeks followed by a 26-week extension period where patients treated with canagliflozin (100 mg or 300 mg) will continue treatment for an additional 26 weeks and patients treated with placebo will be switched to active double-blind treatment with sitagliptin 100 mg, an antihyperglycemic agent administered once-daily for 26 weeks. In addition, all patients will take protocol specified stable doses of metformin and pioglitazone along with assigned study drug for the duration of the study. Patients will participate in the study for approximately 59 to 78 weeks. During the study, if a patient's fasting blood sugar remains high despite treatment with study drug, the patient will receive treatment with glimepiride (rescue therapy) in accordance 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 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. 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) for 52 weeks OR placebo for 26 weeks switched to double-blind sitagliptin 100 mg for 26 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: Placebo One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone. Drug: Canagliflozin One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone. Drug: Sitagliptin One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone. Drug: Metformin The patient's stable dose of metformin background therapy should be continued throughout the study. Drug: Pioglitazone The patient's stable dose of pioglitazone background therapy should be continued throughout the study. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 344 |
| Estimated Completion Date | July 2012 |
| Estimated Primary Completion Date | November 2011 |
| Eligibility Criteria | Inclusion Criteria: - All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin) - Patients in the study must have a HbA1c between >=7 and <=10.5% and 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, Canada, Finland, France, Germany, Greece, India, Mexico, Spain, Thailand, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01106690 |
|---|---|
| Other Study ID Numbers | CR017032 |
| 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 | Anniston, Alabama, United States |
|---|---|
| United States, Arizona | Phoenix, Arizona, United States |
| United States, Arizona | Tucson, Arizona, United States |
| United States, Arkansas | Little Rock, Arkansas, United States |
| United States, California | Burlingame, California, United States |
| United States, California | Encinitas, California, United States |
| United States, California | Fullerton, California, United States |
| United States, California | Roseville, California, United States |
| United States, California | Santa Ana, California, United States |
| United States, California | Wes Hills, California, United States |
| United States, Colorado | Colorado Springs, Colorado, United States |
| United States, Florida | Bartow, Florida, United States |
| United States, Florida | Hollywood, Florida, United States |
| United States, Florida | Jacksonville, Florida, United States |
| United States, Florida | Pembroke Pines, Florida, United States |
| United States, Iowa | Des Moines, Iowa, United States |
| United States, Louisiana | Baton Rouge, Louisiana, United States |
| United States, Minnesota | Chaska, Minnesota, United States |
| United States, Mississippi | Picayune, Mississippi, United States |
| United States, Montana | Billings, Montana, United States |
| United States, North Carolina | Charlotte, North Carolina, United States |
| United States, North Carolina | Hickory, North Carolina, United States |
| United States, North Carolina | Raleigh, North Carolina, United States |
| United States, Ohio | Dublin, Ohio, United States |
| United States, Ohio | Perrysburg, Ohio, United States |
| United States, Oklahoma | Tulsa, Oklahoma, United States |
| United States, Oklahoma | Yukon, Oklahoma, United States |
| United States, Pennsylvania | Bensalem, Pennsylvania, United States |
| United States, Tennessee | Bristol, Tennessee, United States |
| United States, Tennessee | Kingsport, Tennessee, United States |
| United States, Tennessee | Nashville, Tennessee, United States |
| United States, Texas | Arlington, Texas, United States |
| United States, Texas | Dallas, Texas, United States |
| United States, Texas | Grand Prairie, Texas, United States |
| United States, Texas | Houston, Texas, United States |
| United States, Texas | New Braunfels, Texas, United States |
| United States, Texas | San Antonio, Texas, United States |
| United States, Virginia | Falls Church, Virginia, United States |
| United States, Virginia | Virginia Beach, Virginia, United States |
| United States, Washington | Federal Way, Washington, United States |
| United States, Washington | Selah, Washington, United States |
| Canada, New Brunswick | Bathurst, New Brunswick, Canada |
| Canada, New Brunswick | Moncton, New Brunswick, Canada |
| Canada, Newfoundland and Labrador | Grand Falls-Windsor, Newfoundland and Labrador, Canada |
| Canada, Ontario | Brampton, Ontario, Canada |
| Canada, Ontario | Hamilton, Ontario, Canada |
| Canada, Ontario | Ottawa, Ontario, Canada |
| Canada, Ontario | Smiths Falls, Ontario, Canada |
| Canada, Ontario | Thornhill, Ontario, Canada |
| Canada, Quebec | Drummondville, Quebec, Canada |
| Canada | Calgary, Canada |
| Canada | Mount Pearl, Canada |
| Canada | Truro, Canada |
| Finland | Kuopio, Finland |
| Finland | Oulu, Finland |
| Finland | Turku, Finland |
| France | Bondy Cedex, France |
| France | Le Creusot, France |
| France | Narbonne Cedex, France |
| Germany | Aschaffenburg, Germany |
| Germany | Mainz, Germany |
| Germany | Neuwied, Germany |
| Germany | Schkeuditz, Germany |
| Greece | Athens, Greece |
| Greece | Thessaloniki, Greece |
| Greece | Thessalonikis, Greece |
| India | Ahmedabad, India |
| India | Belgaum, India |
| India | Chennai, India |
| India | Coimbatore, India |
| India | Jaipur, India |
| India | Nagpur, India |
| Mexico | Chihuahua, Mexico |
| Mexico | Ciudad Juarez, Mexico |
| Mexico | Durango, Mexico |
| Mexico | Mexico, Mexico |
| Spain | Almería, Spain |
| Spain | Madrid, Spain |
| Spain | Sevilla, Spain |
| Thailand | Bangkok, Thailand |
| Thailand | Khon Kaen, Thailand |
| United Kingdom | Antrim, United Kingdom |
| United Kingdom | Belfast, United Kingdom |