Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
25-60 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
This is a double-blind (neither physician or participant knows name of the assigned study drug), placebo-controlled (substance containing no medication), crossover study in male and female volunteers ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00871507
Start Date
April 1 2009
End Date
July 1 2009
Last Update
May 22 2014
Active Locations (2)
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1
Fort Myers, Florida, United States
2
San Antonio, Texas, United States