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
25-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie, blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of JNJ-28431754 comp...
Detailed Description
This is a randomized (study drug assigned by chance), double-blind (neither physician, patient nor the sponsor knows the assigned treatment), placebo-controlled, single and multiple (14 days) ascendin...
Eligibility Criteria
Inclusion
- Patients must have been diagnosed with Type 2 Diabetes for at least one year before screening
- Patients must be taking a stable dose of oral (by mouth) anti-diabetic monotherapy or a combination of two anti-diabetic medications
- Males or postmenopausal or surgically sterile women (post-menopausal is defined as no menses for at least 18 months prior to study start or no menses for 6 to 18 months)
- Body mass index (weight in kg/height in m2) should be between 20 to 39.9 kg/m2
Exclusion
- History of Type 1, brittle diabetes or secondary forms of diabetes
- History of repeated severe hypoglycemic episodes
- History of diabetic complications including retinopathy, nephropathy, neuropathy, gastroparesis, or ketoacidosis
- History of, or currently active illness including but not limited to cardiovascular disease, hematological disease, respiratory disease, hepatic or gastrointestinal disease, endocrine/metabolic disorders, neurologic or psychiatric disease, or malignant neoplasms considered by the Investigator to be clinically significant
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00963768
Start Date
June 1 2007
End Date
December 1 2007
Last Update
April 23 2014
Active Locations (3)
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1
Chula Vista, California, United States
2
Neuss, Germany
3
Seoul, South Korea