9 results
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
Primary:To estimate the treatment effects of vildagliptin 50 mg PO BID on 24h weighted-mean glucose (WMG), using CGM and plasma glucose, collected at the end of a two-week treatment period.Secondary:1) To estimate the treatment effects of…
Is addition of a DPP4-inhibitor (vildagliptin) beneficial in type 2 diabetic patients, starting on once daily long-acting insulin in combination with 2 dd metformin. Primary end point is necessary dose of insulin to remain glycemic control.…
The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
To optimize glycemic control in acute ischemic stroke patients.
Primary Objective: To determine whether a four week treatment with vildagliptin compared to acarbose improves endothelial dysfunction in patients with type 2 diabetes mellitus.Secondary Objective(s):-To determine the effect of vildagliptin on plasma…
PrimaryThe 3 months* effect of Vildagliptin on insulin synthesis and storage capacitySecondaryThe 3 months* effect of vildagliptin on- Glucose, insulin, C-peptide levels- Hormonal axes, most importantly GLP1 and GIP and Glucagon- Body weight, body…
Primary objective:To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central radiologists* review in subjects with PD-L1 strong, 1L metastatic NSCLC treated with MK-3475 compared to standard of care (SOC…
The purpose of this study is to determine the safety and efficacy of Nilotinib and Vildagliptin as combination therapy in optimal dosage. In addition, it is investigated whether the addition of Vildagliptin to Nilotinib treatment causes the…