26 results
To confirm the effect of continious subcutaneous insulin infusion (CSII treatment) with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 diabetes Mellitus, using a…
This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion, insulin bolus regimen and…
Primary Objectives* Phase 1b lead-in: To assess safety and tolerability of a single dose level of avelumab in combination withincreasing dose levels of other immune modulators in combination with a single doselevel of avelumab in patients with…
To demonstrate superiority with regard to overall survival (OS) of avelumab versus docetaxel in subjects with programmed death ligand 1 (PD-L1) positive (+; as determined by a companion diagnostic test under development), non-small cell lung cancer…
The primary objective of this study is to investigate the effect of hypoglycemia on brain lactate accumulation and regional cerebral blood perfusion in humans. The secondary objective is to assess whether this effect is a related to hypoglycemia…
To compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of…
The aim of this study is to determine whether subcutaneous administration of insulin detemir, as compared to NPH insulin, leads to a more pronounced effect on brain glucose metabolism and blood flow in brain regions associated with appetite…
To compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected with jet-injection to that of the same insulin injected with a conventional pen.
Evaluate the outcomes of a relatively brief but intensive IV insulin therapy compared to conventional therapy in patients admitted for ACS and observe different biomarker washout patterns these treatment groups.Furthermore we wish to determine…
This is a scientific research with the aim to investigate the bioavailability of a combination of the drugs TMC114 and TMC41629 . The three dosage forms, each only once ingested. In addition, even in this study the safety of the use and possible…
To standardize the procedures and analyses to support evaluation of glucose dependent insulin secretion in Type 2 Diabetes Mellitus in subjects with Type 2 Diabetes.
Pharmacology of rapid-acting insulin injected by needle-free jet-injection in patients with diabetes
To compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected with jet-injection to that of the same insulin injected with a conventional pen prior to a standardised meal.
Primary objective: to confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. Secundary objective: to compare…
Objectives:Primary Objective: to investigate the anti-tumor efficacy of domatinostat in combination with avelumab in advanced unresectable/metastatic MCC patients progressing on anti-PD-(L)1 antibody monotherapy.Secondary Objectives: to investigate…
The aim of the study is to develop PD-L1 PET/CT imaging in patients with NSCLC to noninvasively image PD-L1 expression in tumors and to determine the correlation with response to avelumab. For this purpose, two studies will be carried out to1:…
Primary ObjectiveTo demonstrate that avelumab in combination with axitinib is superior to sunitinib monotherapy in prolonging PFS or OS in the first-line treatment of PD-L1 positive patients with aRCC.Secondary Objectives* To demonstrate that…
Primary objective: to investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the awareness of and counterregulatory hormone responses to hypoglycemia in people with type 1 diabetes and impaired awareness of hypoglycemia.…
To demonstrate superiority with regard to Progression Free Survival based on an Independent Review Committeeassessment of avelumab versus platinum-based doublet in NSCLC subjects with PD-L1+
Primary Objective: to evaluate clinical efficacy of domatinostat in combination with avelumab in treatment-naïve metastatic or distally recurrent MCC patients as determined by the Objective Response Rate (ORR) according to Response Evaluation…
To investigate efficacy of neoadjuvant axitinib and avelumab in patients with localized renal cell carcinoma with moderate to high risk of recurrence .