18 results
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.…
To decrease the cumulative incidence of (hematological) relapse
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…
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…
To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…
The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.
The overall objective of this trial is to generate data on the ovarian stimulation profile obtained when Pergoveris® is started either on stimulation day 1 or stimulation day 6 in ART patients between 36 and 40 years of age (both inclusive). A…
• To characterize the systemic response to mucosal immunization with an oral cholera vaccination challenge.• To characterize the local response to intranasal rechallenge after cholera vaccination as outcome measure for nasal mucosal immunity.• To…
The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poorovarian response (POR) patients defined according to modified criteria set forth by the European Society of Human Reproduction and Embryology (…
The primary objective of the main non-inferiority study is to determine the safety of TACmono starting nine months after kidney transplantation in immunologically low-risk patients in terms of BPAR-rate 15 months after transplantation compared to…
The main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
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…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…
Objective(s)* To investigate the pharmacokinetic behaviour of a single dose of MMF;o Plasma concentrationso Cellular concentrationso Relationship between plasma and cellular concentrations* To investigate the pharmacodynamic effects of a single dose…
Safety: To assess the safety and tolerability of BMS-986165 in LNEfficacy: Efficacy: To evaluate the efficacy of BMS 986165 compared with placebo with regard to proteinuria SecondaryEfficacy - To evaluate the efficacy of BMS-986165 with regard to…
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…