A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 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 safety, tolerability, pharmacodynamic effects and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with Type 2 Diabetes Mellitus who are on a stable dose of insulin.

Key facts

Study ID

NCT01177163

Run by

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

People needed

29

Starts

2008-05-01

Expected to finish

2009-03-01

Last updated by the study team

2013-05-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have been diagnosed with T2DM for at least 6 months prior to study screening
• Be on stable insulin regimens at the time of screening
• Have a stable weight (ie, no change more than 5% in the 3 months prior to screening)
• Have a glycosylated hemoglobin (A1C) of >=7% and <=10.5% at study screening

You may not qualify if…

• Have history of Type 1 diabetes mellitus, secondary forms of diabetes, diabetic ketoacidosis, pancreas or beta cell transplantation
• Have a known history of more than 2 severe hypoglycemic episodes as defined by the protocol within the past year
• Have history of, or currently active, significant illness as determined by the Investigator

Where it is running

• Study site — Chula Vista, California, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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