A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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