23 results
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
The primary objective is to demonstrate that glycemic control, as measured by hemoglobin A1c(HbA1c) at 52 weeks for LY2605541 is noninferior to insulin glargine, when each is combined with preprandial insulin lispro, in patients with type 1 diabetes…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
The objective of the study is to gain insight in the role of endogenous GLP-1 on food-stimuli related CNS satiety and reward responses and the alterations between lean and obese-T2DM individuals. Also, to gain information about treatment with a GLP-…
The purpose of the multicenter, randomized, open-label, parallel-group study EFC11628 is to compare the efficacy and safety of HOE901-U300 with that of Lantus®, both given once-daily s.c. as part of a basal-bolus insulin regimen in patients with…
The objective of this observational, randomized study is to examine the efficacy, safety and patient acceptance of the basal plus insulin regimen (i.e. one injection rapid acting insulin glulisine at the main meal added to once daily basal insulin…
The primary objective of this study is to demonstrate the superiority of insulin glargine over liraglutide in termsof percentage of patients reaching a HbA1c < 7% at the end of the comparative period in Type 2 diabetic patientsfailing…
To compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
The overall purpose of the trial is to assess clinical efficacy and safety of three different doses of BI 655066 administered by multiple subcutaneous injections in adult patients with defined ankylosing spondylitis. We will also explore its…
This study has two parts. The main purpose of Part 2 of this study is to see how safe and effective different doses of BI 655064 are as well as to look at the pharmacokinetics (the amount of medication in your blood) and the pharmacodynamics (the…
The primary objective of the study is to demonstrate non-inferiority of an insulin regimen using insulin glargine as the basal insulin with Exubera as the mealtime insulin, compared to a regimen using insulin glargine as the basal insulin and…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…
To demonstrate non-inferiority of Toujeo versus *standard of care* basal insulin therapy asmeasured by HbA1c change from baseline to Month 6.
the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…
The primary objective of this study is to evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with fibroblast growth factor receptor (FGFR) 2 translocation who have failed at least 1…
Voor meer informatie verwijs ik u naar sectie 2 in het protocol
Evaluate efficacy and safety of risankizumab compared to placebo in patients with severe persistent asthma over a 24-week treatment period.
Protocol section 2.1:* Demonstration of the long term safety of BI655130 in patients with moderate to severe active colitis Ulcerosa who have already been treated in previous studies.* Demonstration of the long term efficacy of BI655130 in patients…
see section 21 & 2.2This trial aims to prove the concept of induction of mucosal healing by BI 655130 add-ontherapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activitydespite pre-existing TNFi treatment.…
The goal of the trial is to investigate the safety and efficacy of SAR566658, if it is provided to CA6 protein positive metastaticTBN breastcancer patients.