Phase 3 Completed N=1,450 Randomized Quadruple-blind Treatment

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

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00968812 ↗

Enrolled (actual)

1,450

Serious AEs

8.7%

Results posted

Jun 2013

Primary outcomePrimary: Change in HbA1c From Baseline to Week 52 — -0.82; -0.93; -0.81 Percent

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in HbA1c From Baseline to Week 52	-0.82; -0.93; -0.81	—
SECONDARY Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52	5.6; 4.9; 34.2	<0.001 sig
SECONDARY Percent Change in Body Weight From Baseline to Week 52	-4.2; -4.7; 1.0	<0.001 sig
SECONDARY Change in HbA1c From Baseline to Week 104	-0.65; -0.74; -0.55	—

Eligibility Criteria

Inclusion Criteria

Patients must have a diagnosis of type 2 diabetes
Body mass index (BMI) >=22 to =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

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Data sourced from ClinicalTrials.gov (NCT00968812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.