A Phase 3 interventional study of vildagliptin and Gliclazide in Diabetes Mellitus, Type 2, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 1,092 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: vildagliptin
Drug: Gliclazide
Change from baseline in HbA1c at 104 weeks
Time frame: 104 weeks
Adverse event profile at 104 weeks
Time frame: 104 weeks
Change from baseline in fasting plasma glucose at 104 weeks
Time frame: 104 weeks
Patients with endpoint HbA1c <7% after 104 weeks
Time frame: 104 weeks
Patients with reduction in HbA1c >/= 0.7% after 104 weeks
Time frame: 104 weeks
Patients with reduction in HbA1x >/= 0.5% after 104 weeks
Time frame: 104 weeks
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals