A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of JNJ-38431055 in volunteers with type 2 diabetes mellitus.

Key facts

Study ID: NCT00871507
Run by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
People needed: 25
Starts: 2009-04-01
Expected to finish: 2009-07-01
Last updated by the study team: 2014-05-22

Who can join

Age: 25 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus
Medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ECG performed at Screening
Body Mass Index (BMI) between 22 and 39.9 kg/m2, inclusive
On a generally stable antihyperglycemic agent 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, including volunteers who are:(a) Not currently on antihyperglycemic therapy and have an HbA1c =7.0% and =10.0%, or (b) On a single oral antihyperglycemic agent [metformin, a sulfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a DPP-4 inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)] and have an HbA1c >=6.5% and <=9.5%, or (c) On low-dose dual oral agent therapy (i.e., <50% maximum labeled doses of both agents) and have an HbA1c >=6.5% and <=9.5%
On Day -1, FPG concentrations between 120 mg/dL and 260 mg/dL, inclusive.

You may not qualify if…

Taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other GLP-1 analogues), or taking a thiazolidinedione (i.e., a PPARg agonist) within 3 months of Day -1
History of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness
History of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis
Positive test for alcohol and/or drugs of abuse
Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.

Where it is running

Study site — Fort Myers, Florida, United States
Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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