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, pharmacokinetics (ie, blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.
Key facts
- Study ID
- NCT00963768
- Run by
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- People needed
- 116
- Starts
- 2007-06-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2014-04-23
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Chula Vista, California, United States
- Study site — Neuss, Germany
- Study site — Seoul, South Korea
Full record on ClinicalTrials.gov
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