This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
149
study drug
GSK Investigational Site
Kanagawa, Japan
GSK Investigational Site
Kumamoto, Japan
GSK Investigational Site
Ōita, Japan
GSK Investigational Site
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Fasting Insulin
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Adiponectin
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Time frame: Baseline (Day 0) and Week 16
Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)
Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Time frame: Baseline (Day 0) and Week 16
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.
Time frame: Up to Week 16