EUCTR2022-000743-68-IT进行中（未招募）1 期
A phase II randomized, placebo-controlled, double-blinded, 2-parallel arm, clinical trial evaluating Ladarixin 400 mg twice a day as adjunctive therapy to improve glycemic control in overweight insulin-resistant patients with type 1 diabetes. - N/A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients of both sex aged 21-65 years inclusive, with clinical diagnosis of Type 1 Diabetes for over 1 year and insulin resistance; the presence of at least one or more of Insulin autoantibodies: Anti-GAD;IAA; IA2; ZnT8); detectable fasting C-peptide = 0.02 nmol/L; either established use of an insulin pump or a stable dose level and dose frequency for the last two months; routine use of a self-owned Continuous Glucose Monitoring (CGM) system that can record glucose concentrations continuously for at least 7 days; HbA1c value >7.5%; subject is overweight or obese as per body mass index of between 24-33 kg/m2, inclusive.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 81
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Patients with known or suspected hypersensitivity to the active pharmaceutical ingredient, non-steroidal anti-inflammatory drugs or any excipient of the investigational medicinal product; who use a closed loop system” for integrated glucose reading/insulin infusion; use of non-insulin medications for adjunctive blood glucose control (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors, SGLT-2 inhibitors or amylin) within one month of randomization; use of medications for weight reduction; use of a medication e.g. stimulants, antidepressants and/or psychotropic agents that could affect weight gain or glycemic control of T1D; treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index e.g. phenytoin, warfarin, and high dose of amitriptyline (>50 mg/day); use of angiotensin-converting enzyme inhibitors, interferons, quinidine antimalarial drugs, lithium, niacin; evidence of QTcF >470 msec and a history of significant cardiovascular disease/abnormality; any condition, including unstable diet and disordered eating behaviour, that in the judgment of the investigator will adversely affect patient’s safety or the completion of the protocol or otherwise confound study outcome; pregnancy; clinical diagnosis of celiac disease that is in poor control as defined by most recent tissue transglutaminase (tTG) that is in the abnormal range; history of Diabetic Ketoacidosis (DKA) events in the past 6 months; hypoalbuminemia (serum albumin <3 g/dL); hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 µmol/L]; moderate to severe renal impairment; past or current administration of any immunosuppressive medications and use of any investigational agents, including any agents that impact the immune response; a condition already known which interferes with the ability to accurately determine glycated HbA1c; significant systemic infection during the 4 weeks before the 1st dose of study drug.
研究者
相似试验
进行中（未招募）
1 期
A phase II randomized, placebo-controlled, double-blind, dose-escalation study to evaluate safety, pharmacokinetics and pharmacodynamic dose response relationship of IFX-1 in patients undergoing complex cardiac surgery (CARDIAC)Prevention of organ dysfunction induced by inflammatory response after complex cardiac surgeryMedDRA version: 20.0Level: PTClassification code 10063101Term: Post procedural inflammationSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 20.0Level: LLTClassification code 10062357Term: SIRSSystem Organ Class: 100000004867EUCTR2015-003036-12-DEInflaRx GmbH
进行中（未招募）
1 期
A phase II randomized, placebo-controlled, double-blind, dose controlled trial in patients suffering from early, newly developing abdominal or pulmonary derived septic organ dysfunction to evaluate safety, pharmacokinetics, pharmacodynamics and to estimate efficacy of the new humanized monoclonal i.v. administered antibody CaCP29EUCTR2013-001037-40-DEInflaRx GmbH72
进行中（未招募）
不适用
A Phase II randomized, placebo-controlled, double-blind, dose ranging study of a Clostridium difficile toxoid vaccine (ACAM-CDIFF) in subjects with Clostridium difficile-associated infection(CDI) - N/ARecurrence of Clostridium difficile Infection (CDI)MedDRA version: 12.0Level: LLTClassification code 10006834Term: C.difficile diarrheaMedDRA version: 12.0Level: LLTClassification code 10006835Term: C.difficile diarrhoeaMedDRA version: 12.0Level: LLTClassification code 10012734Term: Diarrhea, Clostridium difficileMedDRA version: 12.0Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileMedDRA version: 12.0Level: LLTClassification code 10022661Term: Intestinal infection due to clostridium difficileMedDRA version: 12.0Level: LLTClassification code 10054236Term: Clostridium difficile infectionEUCTR2008-004907-69-GBSanofi Pasteur Inc.612
进行中（未招募）
1 期
An European study to assess safety and efficacy of a new drug in patients with worsening chronic heart failure.Patient with worsening chronic heart failure with left ventricular systolic dysfunctionMedDRA version: 19.1Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849EUCTR2015-005607-92-HUQuantum Genomics75
进行中（未招募）
1 期
An European study to assass safety and efficacy of a new drug in patients with worsening chronic heart failure.Patient with worsening chronic heart failure with left ventricular systolic dysfunctionMedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000011680EUCTR2015-005607-92-CZQuantum Genomics75