The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 mellitus (T2DM) inadequately controlled with diet and exercise.

Key facts

Study ID

NCT01081834

Run by

Janssen Research & Development, LLC

People needed

678

Starts

2010-03-01

Expected to finish

2012-03-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Concord, California, United States
• Study site — Greenbrae, California, United States
• Study site — Los Angeles, California, United States
• Study site — Spring Valley, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Northglenn, Colorado, United States
• Study site — Springfield, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — Meridian, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — West Seneca, New York, United States
• Study site — Mooresville, North Carolina, United States
• Study site — Perryopolis, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Taylors, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Horn, Austria
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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