A Phase 3 interventional study of vildagliptin and glimepiride in Diabetes Mellitus, Type 2, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 73 Years. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 3,118 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; 229 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: Metformin · Drug: Glimepiride matching placebo
Drug: glimepiride · Drug: Metformin · Drug: Vildagliptin matching placebo
Also known as: LAF237, Galvus
Time to HbA1c >8%
Time frame: 2 year
Change from baseline in HbA1c at 5 years
Time frame: 2 years (amended)
Adverse event profile after 5 years of treatment
Time frame: 2 years (amended)
Coefficient of failure for HbA1c from week 24 to 5 years
Time frame: 2 years (amended)
Change from baseline in fasting plasma glucose at 5 years
Time frame: 2 years (amended)
Change from baseline in body weight at 5 years
Time frame: 2 years (amended)
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