16 results
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…
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…
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* To explore the pharmacokinetics of insulin aspart after pulsed intra-vaginal delivery using the MedRing and after subcutaneous injection in women with DM1.Secondary* To assess the safety and short-term tolerability of insulin aspart after…
Primary objective:To compare the effect of ixa+dex versus pom+dex on progression-free survival (PFS) in patients with relapsed and/or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy, including lenalidomide and…
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
Primary Objective:• To evaluate the proportion of patients with a response of very good partial response (VGPR) or better to IDd treatment.Secondary Objectives:• To measure progression-free survival (PFS), time to progression (TTP), and overall…
Study ObjectivesPrimary:• To determine the effect of ixazomib maintenance therapy on progression-free survival (PFS), compared to placebo, in patients with NDMM who have had a response (complete response [CR], very good partial response [VGPR], or…
Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when administered with subcutaneous (SC) azacitidine and oral AG-221 when administered with SC azacitidine in subjects…
The primary objective of this study is to:• Determine the safety and tolerability of AG-120 and AG-221 when administered with induction and consolidation therapy in patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate…
Primary objective* To determine the efficacy, defined as overall response rate (ORR; >= partial response (PR)), of 9 cycles of ixazomib, daratumumab and low dose dexamethasoneSecondary objectives* To determine the tolerability, defined as…
To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic…