A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

Key facts

Study ID

NCT02025907

Run by

Janssen Research & Development, LLC

People needed

218

Starts

2014-02-01

Expected to finish

2015-09-01

Last updated by the study team

2016-10-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a diagnosis of type 2 diabetes mellitus
• Must have a screening HbA1c of >=7.5% to <=10.5%
• Must be on metformin >=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening

You may not qualify if…

• History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
• A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
• eGFR <60 ml/min/1.73m2, or serum creatinine >=1.4 mg/dL for men and >=1.3 mg/dL for women
• Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
• Major surgery (ie, requiring general anesthesia) within 12 weeks before screening

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Northridge, California, United States
• Study site — Norwalk, California, United States
• Study site — Rancho Cucamonga, California, United States
• Study site — San Ramon, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Cooper City, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Perry, Georgia, United States
• Study site — Shawnee Mission, Kansas, United States
• Study site — Marrero, Louisiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — Metarie, Louisiana, United States
• Study site — Rockville, Maryland, United States
• Study site — Jackson, Mississippi, United States
• Study site — Picayune, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Nashua, New Hampshire, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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