A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
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.