A Phase 3 interventional study of Vildagliptin and metformin in Diabetes Mellitus, Type 2, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 914 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:
Other protocol-defined inclusion/exclusion criteria may apply
Drug: Vildagliptin
Drug: metformin
Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment
Time frame: 24 weeks
Adverse event profile after 24 weeks of treatment
Time frame: 24 weeks
Gastrointestinal tolerability after 24 weeks of treatment
Time frame: 24 weeks
Patients with endpoint HbA1c <7% and <6.5% after 24 weeks
Time frame: 24 weeks
Patients with reduction in HbA1c >0.7% after 24 weeks
Time frame: 24 weeks
Change from baseline in fasting plasma glucose after 24 weeks
Time frame: 24 weeks
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals