CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: JNJ-28431754 (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with type 2 diabetes.

Official title: A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy endpoint is the change in Hemoglobin A1c

Secondary outcome: The percent change in body weight

Detailed description: Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of JNJ-28431754 (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have a diagnosis of type 2 diabetes

- Body mass index (BMI) >=22 to <=45 kg/m2, at screening

- Patients must be taking a stable dosage of metformin as monotherapy at screening

- Patients must have a HbA1c between >=7% and <=9. 5% at Week 2

- Patients must have a fasting plasma glucose (FPG) <=270 mg/dL (15 mmol/L) at Week -2

Exclusion Criteria:

- Patients having prior exposure or known contraindication or suspected

hypersensitivity to JNJ-28431754, glimepiride, or metformin

- 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

- Renal disease requiring treatment with immunosuppressive therapy within the past 12

months before screening or a history of dialysis or renal transplant

- Taken thiazolidinedione therapy in the past 16 weeks before screening

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Quebec, Canada; Not yet recruiting

San Jose, Costa Rica; Not yet recruiting

San Pedro, Costa Rica; Not yet recruiting

Helsinki, Finland; Not yet recruiting

Kuopio, Finland; Not yet recruiting

Oulu, Finland; Not yet recruiting

Turku, Finland; Not yet recruiting

Kokkola, Finland; Not yet recruiting

Berlin, Germany; Not yet recruiting

Dresden, Germany; Not yet recruiting

Duesseldorf, Germany; Not yet recruiting

Hamburg, Germany; Not yet recruiting

Villingen-Schwenningen, Germany; Not yet recruiting

Mainz, Germany; Not yet recruiting

Hyderabad, India; Not yet recruiting

Nagpur, India; Not yet recruiting

Bangalore, India; Not yet recruiting

Coimbatore, India; Not yet recruiting

Chennai, India; Not yet recruiting

Hyderabad N/A, India; Not yet recruiting

Pune, India; Not yet recruiting

Ahmedabad, India; Not yet recruiting

Wardha, India; Not yet recruiting

Jerusalem, Israel; Not yet recruiting

Zefat, Israel; Not yet recruiting

Tel Aviv, Israel; Not yet recruiting

Holon, Israel; Not yet recruiting

Zerifin, Israel; Not yet recruiting

Haifa, Israel; Not yet recruiting

Beer Sheba, Israel; Not yet recruiting

Hadera, Israel; Not yet recruiting

Tel-Aviv, Israel; Not yet recruiting

Seoul, Korea, Republic of; Not yet recruiting

Gyeonggi-Do, Korea, Republic of; Not yet recruiting

Suwon, Korea, Republic of; Not yet recruiting

Kyonggi-Do, Korea, Republic of; Not yet recruiting

Incheon, Korea, Republic of; Not yet recruiting

Ciudad De Mexico, Mexico; Not yet recruiting

Monterrey, Mexico; Not yet recruiting

Mexico, Mexico; Not yet recruiting

Oslo, Norway; Not yet recruiting

Hamar, Norway; Not yet recruiting

Alesund, Norway; Not yet recruiting

Quezon City, Philippines; Not yet recruiting

Marikina City, Philippines; Not yet recruiting

Pasay, Philippines; Not yet recruiting

Cebu, Philippines; Not yet recruiting

Torun, Poland; Not yet recruiting

Lisboa, Portugal; Not yet recruiting

Coimbra, Portugal; Not yet recruiting

Leiria, Portugal; Not yet recruiting

Aveiro, Portugal; Not yet recruiting

Bucharest, Romania; Not yet recruiting

Brasov, Romania; Not yet recruiting

Cluj, Romania; Not yet recruiting

Baia Mare, Romania; Not yet recruiting

Galati, Romania; Not yet recruiting

Ploiesti, Romania; Not yet recruiting

Targu Mures, Romania; Not yet recruiting

Saint Petersburg, Russian Federation; Not yet recruiting

Bratislava, Slovakia; Not yet recruiting

Banska Bystrica, Slovakia; Not yet recruiting

Lubochna, Slovakia; Not yet recruiting

Presov, Slovakia; Not yet recruiting

Dnepropetrovsk, Ukraine; Not yet recruiting

Kiev, Ukraine; Not yet recruiting

Vinnitsa, Ukraine; Not yet recruiting

Kharkov, Ukraine; Not yet recruiting

Poltava, Ukraine; Not yet recruiting

Columbiana, Alabama, United States; Not yet recruiting

Gilbert, Arizona, United States; Not yet recruiting

Mesa, Arizona, United States; Not yet recruiting

Tucson, Arizona, United States; Not yet recruiting

Jonesboro, Arkansas, United States; Not yet recruiting

Chilliwack, British Columbia, Canada; Not yet recruiting

Vancouver, British Columbia, Canada; Not yet recruiting

Kelowna, British Columbia, Canada; Not yet recruiting

San Diego, California, United States; Not yet recruiting

Roseville, California, United States; Recruiting

Westlake Village, California, United States; Not yet recruiting

Encinitas, California, United States; Not yet recruiting

Buena Park, California, United States; Not yet recruiting

Washington, District of Columbia, United States; Not yet recruiting

Gainesville, Florida, United States; Not yet recruiting

Altamonte Springs, Florida, United States; Not yet recruiting

Oldsmar, Florida, United States; Not yet recruiting

Marianna, Florida, United States; Not yet recruiting

Augusta, Georgia, United States; Recruiting

Perry, Georgia, United States; Recruiting

Nampa, Idaho, United States; Recruiting

New Orleans, Louisiana, United States; Not yet recruiting

Elkridge, Maryland, United States; Not yet recruiting

Las Vegas, Nevada, United States; Not yet recruiting

St. John'S, Newfoundland and Labrador, Canada; Not yet recruiting

Tulsa, Oklahoma, United States; Not yet recruiting

Yukon, Oklahoma, United States; Not yet recruiting

Toronto, Ontario, Canada; Not yet recruiting

Mississauga, Ontario, Canada; Not yet recruiting

Fleetwood, Pennsylvania, United States; Not yet recruiting

Charlottetown, Prince Edward Island, Canada; Not yet recruiting

Saskatoon, Saskatchewan, Canada; Not yet recruiting

Greenville, South Carolina, United States; Recruiting

Nashville, Tennessee, United States; Not yet recruiting

Pearland, Texas, United States; Not yet recruiting

San Antonio, Texas, United States; Not yet recruiting

Odessa, Texas, United States; Not yet recruiting

Virginia Beach, Virginia, United States; Recruiting

Olympia, Washington, United States; Not yet recruiting

Milwaukee, Wisconsin, United States; Not yet recruiting

Wauwatosa, Wisconsin, United States; Not yet recruiting

To learn how to participate in this trial please click here.

Starting date: August 2009
Ending date: January 2013
Last updated: September 25, 2009