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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental |
| |
| 002 | Experimental |
| |
| 003 | Placebo Comparator |
| |
| 004 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-38431055 Dose 1 | Drug | Liquid suspension/solution of JNJ-38431055 administered as a single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental glucose AUC after an oral glucose tolerance test (OGTT) | 0-4 hours after OGTT |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Myers | Florida | United States | ||||
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| Sitagliptin 100 mg |
| Drug |
Capsule containing 100 mg of sitagliptin administered as a single dose. |
|
| Placebo | Drug | Placebo suspension/solution and Placebo capsule administered as single doses |
|
| JNJ-38431055 Dose 2 | Drug | Liquid suspension/solution of JNJ-38431055 administered as a single dose |
|
| 0-4 hours after OGTT |
| Pharmacokinetics | 48 hours after dosing |
| Safety and Tolerability | Throughout study |
| San Antonio |
| Texas |
| United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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