Glibenclamide (Dose to be Titrated From Starting Dose of 5mg om) Plus Rosiglitazone 4mg om (Increased to 8mg om After 6 Months) and vs Glibenclamide (Dose to be Titrated With Starting Dose of 5mg om) Plus Placebo, Administered to Patients With Type 2 Diabetes Mellitus

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

February 28, 2006

Study Completion Date

February 28, 2006

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

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 7% for 2 subsequent visits, the patient will be withdrawn from the study.

DRUG

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 7% for 2 subsequent visits, the patient will be withdrawn from the study.

Trial Locations (4)

110-744

GSK Investigational Site, Seoul

120-752

GSK Investigational Site, Seoul

135-710

GSK Investigational Site, Seoul

137-701

GSK Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01045590 - Glibenclamide (Dose to be Titrated From Starting Dose of 5mg om) Plus Rosiglitazone 4mg om (Increased to 8mg om After 6 Months) and vs Glibenclamide (Dose to be Titrated With Starting Dose of 5mg om) Plus Placebo, Administered to Patients With Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter