CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00968812
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.
- 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 canagliflozin compared with a sulfonylurea (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 canagliflozin (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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1452
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Canagliflozin 300 mg Canagliflozin (JNJ-28431754) Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Canagliflozin 100 mg Canagliflozin (JNJ-28431754) Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Glimepiride Glimepiride Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Glimepiride Metformin Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Canagliflozin 300 mg Metformin Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Canagliflozin 100 mg Metformin Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Week 52 Day 1 (Baseline) and 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 analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 Day 1 (Baseline) and Week 52 The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.
Percent Change in Body Weight From Baseline to Week 52 Day 1 (Baseline) and Week 52 The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.
Change in HbA1c From Baseline to Week 104 Baseline, Week 104 The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.