Status:
COMPLETED
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes...
Detailed Description
Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), doubl...
Eligibility Criteria
Inclusion Criteria:
- All patients must have a diagnosis of T2DM
- Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and <=10% and a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)
- Patients in the High Glycemic Cohort Substudy must have an HbA1c between >10% and <=12% and a FPG <=350 mg/dL (19.44 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
678 Patients enrolled
Trial Details
Trial ID
NCT01081834
Start Date
March 1 2010
End Date
March 1 2012
Last Update
February 23 2017
Active Locations (78)
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Phoenix, Arizona, United States
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Concord, California, United States
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Los Angeles, California, United States