An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: Canagliflozin 150 mg; Drug: Placebo; Drug: Canagliflozin 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01340664

2010-024256-28 (EudraCT Number)

CR017914

28431754DIA2003 (Other Identifier)

Details and patient eligibility

About

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 receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

Full description

This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study doctor will know the identity of assigned study drug), placebo-controlled, parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in appearance to canagliflozin but does not contain active drug) in patients with type 2 diabetes mellitus (T2DM) who are not achieving an adequate response from current antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1 capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if applicable, for up to 18 weeks. The dosing time of metformin should remain the same throughout the study.

Enrollment: 279 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients must have a diagnosis of T2DM and be currently treated with metformin
• Patients in the study must have a HbA1c between >=7 and <=10.5%
• Patients must have 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, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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279 participants in 3 patient groups, including a placebo group

Canagliflozin 50 mg bid

Experimental group

Description:

Each patient will receive 50 mg canagliflozin twice daily for 18 weeks.

Treatment:

Drug: Metformin

Drug: Canagliflozin 50 mg

Canagliflozin 150 mg bid

Experimental group

Description:

Each patient will receive 150 mg canagliflozin twice daily for 18 weeks

Treatment:

Drug: Metformin

Drug: Canagliflozin 150 mg

Placebo

Placebo Comparator group

Description:

Each patient will receive matching placebo twice daily for 18 weeks

Treatment:

Drug: Metformin

Drug: Placebo