| Trial ID: | L2683 |
| Source ID: | NCT00519480
|
| Associated Drug: |
Gsk189075
|
| Title: |
A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GSK189075|DRUG: Metformin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Clinical laboratory tests, ECGs, physical exam & adverse events:, screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days)|Home diary of blood sugar results, adverse events and drug dosing., throughout the study (approximately 50 days) | Secondary: study drug blood levels:, Dosing Days 1 & 13 metformin blood levels: Days -1 & 13|Blood glucose & insulin levels following oral glucose challenge:, Dosing Days -1 & 13|fluid intake & output, dosing Days -1 - 3, 13
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-09-11
|
| Completion Date: |
2008-04-01
|
| Results First Posted: |
|
| Last Update Posted: |
2017-09-06
|
| Locations: |
GSK Investigational Site, Miami, Florida, 33169, United States|GSK Investigational Site, San Antonio, Texas, 78209, United States|GSK Investigational Site, Buenos Aires, 1425, Argentina|GSK Investigational Site, Berlin, 14050, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00519480
|
