18 results
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…
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 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…
To demonstrate non-inferiority of Toujeo versus *standard of care* basal insulin therapy asmeasured by HbA1c change from baseline to Month 6.
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet…
PrimaryPhase 1-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory cHL, DLBCL or PTCL, and to confirm the recommended Phase 2 dose (RP2D).Phase 2- Cohort A1 (anti-…
Primary Efficacy Objective:Primary objective: To evaluate if the addition of ISA101b to cemiplimab results in improved overall response rate (ORR) compared to cemiplimab alone, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1…
The primary objective:To determine the safety and tolerability of 89Zr*DFO*REGN5054 alone and in combination with cemiplimab.Secondary ObjectivesFor Part A:• To characterize the radioactivity pharmacokinetic (PK) profile of 89Zr DFO REGN5054• To…
From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab 1600 mg + cemiplimab and/or fianlimab 400 mg+ cemiplimab compared to pembrolizumab, as measured by progression-…
Primary ObjectivesIn the Dose Escalation Phase:• To assess the safety and pharmacokinetics (PK) in order to determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimabIn…
The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR).The secondary objectives of the study are:• To characterize the…
The evaluation of R-IrAE's after ICI therapy, specifically incidence, treament of R-IrAE's, response to said treatment, baseline and follow-up serology (general and symptom specific) to be combined with quality of life assessment and…
Primary objective: 1) To evaluate the overall response rate (ORR) after 24 weeks of cemiplimab in secondary angiosarcomas, according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 or daylight photography as per WHO Offset Publication…
Primary Objectives: Dose Escalation (SAR441000 Monotherapy): -To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the overall safety and tolerability profile of SAR441000 when administered intratumorally as…