| Trial ID: | L5182 |
| Source ID: | NCT00432679
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| Associated Drug: |
Rosiglitazone (Brl49653c)
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| Title: |
A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00432679/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Rosiglitazone (BRL49653C)
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| Outcome Measures: |
Primary: 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)., Baseline (Day 0) and Week 16 | Secondary: 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., 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., 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., 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., 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., 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., 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., 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., Up to Week 16
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| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
149
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2006-05-24
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| Completion Date: |
2007-03-28
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| Results First Posted: |
2019-02-08
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| Last Update Posted: |
2022-12-12
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| Locations: |
GSK Investigational Site, Kanagawa, 212-0024, Japan|GSK Investigational Site, Kumamoto, 862-0976, Japan|GSK Investigational Site, Oita, 870-0039, Japan|GSK Investigational Site
|
| URL: |
https://clinicaltrials.gov/show/NCT00432679
|
