Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519480
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2007-08-20
Brief Title:
A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of 2000mg of Metformin
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Two-Week Randomized Double-Blind Repeat-Dose Parallel-Group Study to Evaluate the Safety and Tolerability of Metformin 2000mg Co-Administered With Either GSK189075 500mg BID or GSK 189075 750mg BID to Subjects With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes About 48 people will participate in this study Volunteers will not know if they are receiving GSK189075 or a placebo Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily a 13-day treatment period and a follow-up visit about 1 week after the treatment period Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose They will have clinic visits on dosing Days 6 8 and 10 Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary Blood pressure heart rate laboratory tests on blood and urine physical examinations reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None