A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) 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 pharmacokinetics (blood levels of the drug) and pharmacodynamics (effects of the drug on the body) of canagliflozin after oral administration to patients with type 2 diabetes mellitus.
Key facts
- Study ID
- NCT01128985
- Run by
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- People needed
- 39
- Starts
- 2010-03-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2013-05-29
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients must have a diagnosis of T2DM for at least 1 year, but not more than 12 years prior to Day -1 of the study and be medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and electrocardiogram (ECG) performed at Screening
- Patients must be on generally stable approved anti-hypeglycemic agent (AHA) regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the Screening Visit
- Patients must have fasting plasma glucose (FPG) concentrations between 7.8 mM (140 mg/dL) and 15 mM (270 mg/dL) on Day -2
You may not qualify if…
- History of clinically significant diabetic complications including retinopathy, nephropathy, or macro albuminuria, neuropathy, gastroparesis, or diabetic ketoacidosis
- History of type 1 diabetes mellitus (T1DM)
- History of repeated severe hypoglycemic episodes before screening
Where it is running
- Study site — Fort Myers, Florida, United States
- Study site — Miramar, Florida, United States
Full record on ClinicalTrials.gov
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