| Trial ID: | L6734 |
| Source ID: | NCT00871507
|
| Associated Drug: |
Jnj-38431055 Dose 1
|
| Title: |
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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: JNJ-38431055 Dose 1|DRUG: Sitagliptin 100 mg|DRUG: Placebo|DRUG: JNJ-38431055 Dose 2
|
| Outcome Measures: |
Primary: Incremental glucose AUC after an oral glucose tolerance test (OGTT), 0-4 hours after OGTT | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-04
|
| Completion Date: |
2009-07
|
| Results First Posted: |
|
| Last Update Posted: |
2014-05-22
|
| Locations: |
Fort Myers, Florida, United States|San Antonio, Texas, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00871507
|
