Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2
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 with type 2 diabetes mellitus.
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 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 hypoglycemic drugs (28 days), a treatment phase during which volunteers will continue to be off their oral hypoglycemic drugs (28 days) and will receive 4 single dose study treatments in a randomized (study sequence assigned by chance) sequence, and a follow-up phase (10 days). After the follow-up phase volunteers will restart their oral hypoglycemic drugs. During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo. 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 outcome will be incremental glucose after an oral glucose tolerance test. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin (Januvia), and placebo.
Interventions
DRUGJNJ-38431055 Dose 1
Liquid suspension/solution of JNJ-38431055 administered as a single dose
Capsule containing 100 mg of sitagliptin administered as a single dose.
DRUGPlacebo
Placebo suspension/solution and Placebo capsule administered as single doses
DRUGJNJ-38431055 Dose 2
Liquid suspension/solution of JNJ-38431055 administered as a single dose
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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 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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental glucose AUC after an oral glucose tolerance test (OGTT) | 0-4 hours after OGTT |
Secondary
| Measure | Time frame |
|---|---|
| Incremental glucose AUC after a meal tolerance test (MTT) | 0-4 hours after MTT |
| Measurements of beta-cell function | 0-4 hours after OGTT/MTT |
| Effect on incretin levels | 0-4 hours after OGTT |
| Pharmacokinetics | 48 hours after dosing |
| Safety and Tolerability | Throughout study |
Countries
United States
Outcome results
None listed