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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01340664

Run by

Janssen Research & Development, LLC

People needed

279

Starts

2011-07-01

Expected to finish

2012-04-01

Last updated by the study team

2014-09-16

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 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)

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 — National City, California, United States
• Study site — Spring Valley, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Marianna, Florida, United States
• Study site — Savannah, Georgia, United States
• Study site — Avon, Indiana, United States
• Study site — Valparaiso, Indiana, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Metairie, Louisiana, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Mason, Ohio, United States
• Study site — Perrysburg, Ohio, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Yukon, Oklahoma, United States
• Study site — Oregon City, Oregon, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — East Providence, Rhode Island, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Pearland, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Bountiful, Utah, United States
• Study site — Virginia Beach, Virginia, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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