A Phase 3 interventional study of rosiglitazone maleate/metformin hydrochloride in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 102 sites in 7 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-03-21.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 453 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
rosiglitazone maleate/metformin hydrochloride
Change from baseline in hemoglobin A1c (HbA1c) at week 32.
Time frame: at 32 week
Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks
Time frame: at 32 weeksInvalid value
Showing the first 100 of 102 sites across 7 countries.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline