Overview

The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
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 and sulphonylurea and have inadequate glycemic (blood sugar) control.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Canagliflozin
Metformin
Criteria
Inclusion Criteria:

- All patients must have a diagnosis of T2DM and be currently treated with metformin and
sulphonylurea

- 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, or diabetes secondary to pancreatitis or pancreatectomy, or a
severe hypoglycemic episode within 6 months before screening