| Trial ID: | L5840 |
| Source ID: | NCT00508287
|
| Associated Drug: |
Bms-686117
|
| Title: |
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: BMS-686117|DRUG: Byetta|DRUG: Placebo
|
| Outcome Measures: |
Primary: Safety: incidence of adverse events, from subject enrollment to study discharge | Secondary: PK parameters: Cmax, Tmax, AUC(0-24h), AUC(INF) and T-HALF, from pre-dose to 24 hrs post-dose|PD Measures: Fasting and postprandial serum glucose (AUC), serum insulin, and plasma glucagon concentrations. Acetaminophen plasma concentrations will be measured after a single dose of acetaminophen, from pre-dose to 9 hrs post-dose
|
| Sponsor/Collaborators: |
Sponsor: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-08
|
| Completion Date: |
2007-11
|
| Results First Posted: |
|
| Last Update Posted: |
2009-03-16
|
| Locations: |
Elite Research Institute, Miami, Florida, 33169, United States|Orlando Clinical Research Center, Orlando, Florida, 32809, United States|New Orleans Center For Clinical Research, Knoxville, Tennessee, 37920, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00508287
|
