41 results
There is no formal research hypothesis for this study. The purpose is to evaluate the effects of dapagliflozin on kidney function (GFR) and the changes from baseline in the ambulatory Blood Pressure. The effects of dapagliflozin on red cell mass and…
To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function in* full…
The main objective of the study is to determine the albuminuria lowering effect of the GLP1-RA exenetide, SGLT-2 inhibitor dapagliflozin and their combination in patients with type 2 diabetes and micro- or macroalbuminuria.Secondary objectives are…
The aim of the study is to investigate effects of dapagliflozin on potential mechanisms explaining improved insulin sensitivity in skeletal muscles.
Primary ObjectivesParts 1 (Subjects with F/MF genotypes) and 2 (Optional; Subjects with the F/F genotype)* To evaluate the safety and tolerability of VX 121 in TC with TEZ/VX 561 (deuterated IVA) * To evaluate the efficacy of VX 121 in TC with TEZ/…
The primary objective is to assess in a 2x2 crossover design, whether compared to placebo dapagliflozin 10 mg od for 13 weeks improves LV distensibility, measured with echocardiography in patients with early HFpEF (LVEF >= 50%), defined as…
Primary objective:To investigate the separate and combined actions of the SGLT2 inhibitor dapagliflozin and GLP-1 receptor agonist exenatide on activity in central reward and satiety circuits in response to food related stimuli in obese patients…
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.…
Main objective:Part ATo evaluate the long-term safety and tolerability of VX-661 in combination with ivacaftor in subjects with CF, homozygous or heterozygous for the F508del-CFTR mutation who are in the Treatment Cohort.Part B and Part CNot…
To assess the albuminuria lowering effects of dapagliflozin in subjects with and without diabetes or hypertension and persistent elevated albuminuria.
In this study, we want to investigate the effect of the change in co-medication from lumacaftor to tezacaftor on the kinetics and exposure levels of ivacaftor described by the through concentrationsPrimary Objective: - the through concentration of…
To gain more knowledge about the effects of SGLT2 inhibition on renal hemodynamics and the underlying mechanisms.
The primary objective of this study is to evaluate the effect of multiple doses of azithromycin, clarithromycin and ritonavir on the pharmacokinetics, safety and tolerability of a single oral 150 mg dose of ivacaftor in healthy controls and in…
Main objectivePart A: To evaluate the safety and efficacy of treatment with VX-371, administered with and without 4.2% hypertonic saline (HS) in subjects with primary ciliary dyskinesia (PCD) who are *12 years of age.Part B: To evaluate the safety…
Primary: * To assess the change baseline in 24-hr proteinuria with dapagliflozin for six weeks relative to placebo treatment in patients with non-diabetic kidney disease and proteinuria > 500 mg/day on stable ACEi or ARB treatment. Secondary…
ObjectivesPrimary objectiveThe primary objective is to determine the effect of dapagliflozin relative to placebo oncardiovascular outcomes when added to current background therapy in patients with type 2diabetes mellitus (T2DM) with either…
Primary Objective The primary objective of this study is to compare the change from baseline in HbA1c after 24 weeks of double blinded treatment with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin.…
To explore the inflammatory changes of dapagliflozin compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus using insulin.
Primary Objective:To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) andivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and aminimal function mutation (F/MF subjects)Secondary…
Primary Objective:To evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)Secondary Objectives:* To evaluate the…