A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to evaluate the effect of canagliflozin on post-meal glucose blood levels in patients with Type 2 Diabetes Mellitus.

Key facts

Study ID

NCT01381887

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

37

Starts

2011-06-01

Expected to finish

2011-11-01

Last updated by the study team

2013-04-22

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with T2DM with inadequate glycemic control (based upon fasting glucose measurements >=130 mg/dL and <=250 mg/dL) on metformin monotherapy or on metformin in dual combination with other glucose lowering agents (sulphonylurea [SU] or a meglitinide or a dipeptidyl peptidase-4 [DPP-4] inhibitor) are eligible for enrollment in the study.

You may not qualify if…

• History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
• history of a severe hypoglycemic episode within 6 months before screening
• Has repeated (ie, 2 or more over a 1-week period) fasting plasma glucose (FPG) and/or fasting self-monitored blood glucose (SMBG) measurements >=250 mg/dL (13.88 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
• History of or current illness considered to be clinically significant by the investigator

Where it is running

• Study site — Chula Vista, California, United States
• Study site — Miramar, Florida, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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