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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Glimepiride

Drug: Metformin

Drug: Canagliflozin (JNJ-28431754)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00968812

CR016480

2009-009320-36 (EudraCT Number)

28431754DIA3009 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,452 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,452 participants in 3 patient groups

Glimepiride

Active Comparator group

Description:

Each patient will receive glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.

Treatment:

Drug: Glimepiride

Drug: Metformin

Canagliflozin 100 mg

Experimental group

Description:

Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.

Treatment:

Drug: Metformin

Drug: Canagliflozin (JNJ-28431754)

Canagliflozin 300 mg

Experimental group