A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
- Registration Number
- NCT00432679
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arm 1 Rosiglitazone (BRL49653C) study drug
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group Baseline (Day 0) and Week 16 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).
- Secondary Outcome Measures
Name Time Method Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG) Baseline (Day 0) and Week 16 Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Change From Baseline After 16 Weeks of Treatment in Adiponectin Baseline (Day 0) and Week 16 Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Change From Baseline After 16 Weeks of Treatment in Fasting Insulin Baseline (Day 0) and Week 16 Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin Baseline (Day 0) and Week 16 Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Baseline (Day 0) and Week 16 Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta) Baseline (Day 0) and Week 16 Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP) Baseline (Day 0) and Week 16 Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment Up to Week 16 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.
Trial Locations
- Locations (1)
GSK Investigational Site