Status:
COMPLETED
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 Me...
Detailed Description
This is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group (each group of patients will b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01177163
Start Date
May 1 2008
End Date
March 1 2009
Last Update
May 29 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Chula Vista, California, United States
2
San Antonio, Texas, United States