| Trial ID: | L7124 |
| Source ID: | NCT00733577
|
| Associated Drug: |
Sb756050
|
| Title: |
A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: SB756050
|
| Outcome Measures: |
Primary: Safety measures including: AEs daily; laboratory testing: day -1,2,5,7 and follow up; ECG: day -1, 2, 5, 6, 7 and follow-up; vital signs: daily; PK parameters day -1,5, and 6., 6 days of dosing | Secondary: Pharmacodynamic endpoints will include fasting and meal or OGTT-related weighted mean AUC for glucose, GLP-1 (total and active), glucagon, insulin, PYY (active) and C-peptide levels., 6 days of dosing|Safety and tolerability parameters including adverse events, clinical laboratory, ECGs and vital signs assessments., 6 days of dosing|Subject reports of hunger and craving as reported on the Hunger and Craving questionnaire, 6 days of dosing
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-08-11
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| Completion Date: |
2009-03-03
|
| Results First Posted: |
|
| Last Update Posted: |
2017-07-13
|
| Locations: |
GSK Investigational Site, Miami, Florida, 33169, United States|GSK Investigational Site, Orlando, Florida, 32809, United States|GSK Investigational Site, Hackensack, New Jersey, 07601, United States|GSK Investigational Site, San Antonio, Texas, 78209, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00733577
|
