100
Participants
Start Date
December 31, 2003
Primary Completion Date
February 28, 2006
Study Completion Date
February 28, 2006
titration
Patients in the glibenclamide plus placebo treatment group Patients in the glibenclamide plus placebo treatment group who have FPG \< 270mg/dL after the glibenclamide 5mg om run-in will continue to receive glibenclamide 5mg om. At every subsequent visit, the glibenclamide dose will be titrated to achieve the target HbA1c level of \< 7%. If the HbA1c is \> 7%, the dose of glibenclamide will be escalated in the following sequence: from 5mg om, to 5mg om, 2.5mg on, to 5mg bd and 7.5mg om, 5mg on, to 7.5mg bd. The maximum total daily dose will not exceed 15 mg. A downward titration of glibenclamide using the above sequence in the reverse order can be used to maintain normoglycemia at any visit. Once the target HbA1c level of \< 7% is achieved, the dose of glibenclamide is maintained. If at the glibenclamide dose of 7.5mg bd, the HbA1c is \> 7% for 2 subsequent visits, the patient will be withdrawn from the study.
titration
Patients in the glibenclamide + rosiglitazone treatment group who have FPG \< 270mg/dL after the glibenclamide 5mg om run-in will receive glibenclamide 5mg om + rosiglitazone 4mg om. At every subsequent visit, the glibenclamide dose will be titrated to achieve the target HbA1c level of \< 7%. If the HbA1c is \> 7%, the dose of glibenclamide will be escalated in a similar fashion as above. The only exception is at visit 5 when the dose of rosiglitazone is increased (see next paragraph). Once the target HbA1c level of \< 7% is achieved, the dose of glibenclamide is maintained. If at the glibenclamide dose of 7.5mg bd, the HbA1c is \> 7% for 2 subsequent visits, the patient will be withdrawn from the study.
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
Lead Sponsor
GlaxoSmithKline
INDUSTRY