A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus

Johnson & Johnson (J&J)

Status and phase

Terminated

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: JNJ-38431055; Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00946972

CR016447

Details and patient eligibility

About

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 multiple doses of JNJ-38431055 in volunteers with type 2 diabetes mellitus.

Full description

This is a double-blind (neither physician or participant knows the name of the assigned study drug), placebo-controlled (substance containing no medication), study in male and female volunteers with type 2 diabetes mellitus. For each volunteer, the study consists of a screening phase (up to 45 days), a run-in phase during which volunteers discontinue their oral anti-hyperglycemic drugs (21 to 35 days), a treatment phase during which volunteers will continue to be off their anti-hyperglycemic drugs and receive daily study drug (JNJ-38431055 or placebo) for 14 days, and a follow-up phase (10 days). After the follow-up phase, volunteers will restart their oral anti-hyperglycemic drugs. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), blood pressure, heart rate, and blood samples for laboratory tests. The primary outcomes will be safety and tolerability of JNJ-38431055 and 24-hour weighted mean glucose concentrations after 14 days of dosing with JNJ-38431055. Study drug will be administered as daily doses for 14 days. The two treatments will be JNJ-38431055 and placebo.

Enrollment

33 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 Screening visit, including volunteers who are: (a) Not currently on antihyperglycemic therapy and have an HbA1c >=7.0 % and <=10%, or (b) On a single oral antihyperglycemic agent [metformin, a sunfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a DPP-IV 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 -2 (two days prior to study drug administration), FPG concentrations between 120 mg/dL and 260 mg/dL, inclusive

Exclusion criteria

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 the Screening visit
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