2024-513560-26-00招募中2 期
A phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the effect and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a low residual β-cell function at baseline.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 103
- 试验地点
- 13
- 主要终点
- - Change from baseline in 2-hour AUC of C-peptide response to the MMTT [Primary endpoint. Time frame: Month 6].
研究概览
简要总结
The objective of this clinical trial is to assess whether ladarixin treatment has an effect to preserve Beta-cell function and delay the progression of T1D in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- An optional PK sub-study is part of the trial
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female patients aged 14-45 years, inclusive;
- •Recent onset T1D (1st IMP dose within 180 days from 1st insulin administration);
- •Positive for at least one diabetes-related auto-antibody (anti-GAD; IAA, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody; ZnT8);
- •Require, or has required at some time insulin therapy through one or more separate subcutaneous injections or Continuous Subcutaneous Insulin Infusion (CSII).
- •Fasting C peptide < 0.205nmol/L
- •Residual β-cell function as per peak stimulated (MMTT) C-peptide level >0.2nmol/L; MMTT should not be performed within one week of resolution of a diabetic ketoacidosis event
- •Patient able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
- •Patients who have given written informed consent prior of any study-related procedure not part of standard medical care (participants under the age of 18, shall provide an assent for the study as per country requirements). Specific consent must be given by adolescents to be selected for the full PK analysis.
排除标准
- •A type 2 diabetes diagnosis or any other unstable chronic disease for which dose adjustment of specific medication is anticipated during the trial
- •Previous (past 2 weeks) and concomitant treatment withantidiabetic agents as metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors, SGLT-2 inhibitors or amylin, or any medications known to influence glucose tolerance (e.g. beta-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine antimalarial drugs, lithium, niacin, etc.)
- •Past (past month) or current administration of any immunosuppressive medications (including oral or systemic corticosteroids) and use of any investigational agents, including any agents that impact the immune response or the cytokine system
- •Significant systemic infection during the 4 weeks before the 1st dose of study drug (e.g., infection requiring hospitalization, major surgery, or i.v. antibiotics to resolve; other infections, e.g. bronchitis, sinusitis, localized cellulitis, candidiasis, or urinary tract infections, must be assessed on a case-by-case basis by the investigator regarding whether they are serious enough to warrant exclusion)
- •History of positive status for hepatitis A (IgM), hepatitis B (not due to immunization), hepatitis C and HIV
- •Pregnant or breast-feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males). Effective contraceptive measures include a hormonal birth control (e.g. oral pills, long term injections, vaginal ring, patch); the intrauterine device (IUD); a double barrier method (e.g. condom or diaphragm plus spermacide foam); abstinence.
- •Moderate to severe renal impairment as per estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73m2, as determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- •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]
- •Hypoalbuminemia defined as serum albumin <3 g/dL
- •QTcF > 470 msec
- •Occurrence of an episode of ketoacidosis or hypoglycemic coma in the past 2 weeks
- •A history of significant cardiovascular disease/abnormality
- •Known hypersensitivity to non-steroidal anti-inflammatory drugs
- •Concomitant treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index [i.e. phenytoin, warfarin, sulphanylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose of amitriptyline (>50 mg/day)]
结局指标
主要结局
- Change from baseline in 2-hour AUC of C-peptide response to the MMTT [Primary endpoint. Time frame: Month 6].
- Change from baseline in 2-hour AUC of C-peptide response to the MMTT [Primary endpoint. Time frame: Month 6].
次要结局
- Change from baseline in 2-hour AUC of C-peptide response to the MMTT [Time frame: month 12, 18 and 24].
- Change in HbA1c from baseline [Time frame: Month 6, 12, 18 and 24].
- Time in range (TIR) by Continuous Glucose Monitoring (CGM) [Time frame: Month 6, 12, 18, 24].
- Proportion of patients with HbA1c <7% who did not experience severe hypoglycemic events during treatment [Time frame: Month 6, 12, 18 and 24].
- Average (previous 3 days) daily insulin requirement (IU/kg/day) [Time frame: Month 6, 12, 18 and 24].
- Proportion of patients with HbA1c <7% and daily insulin requirement <0.5 (IU/kg/day) [Time frame: Month 6, 12, 18 and 24].
- Additional Glucose Variability Indices derived from CGM (glucose AUC outside the target range of 70 – 180 mg/dL, 2-hour postprandial glucose (PPG), Mean Amplitude Glycemic Excursions (MAGE), continuous overall net glycemic action (CONGA)-n, Mean Of the Daily Differences (MODD), and mean daily blood glucose, SD (Standard Deviation). [Time frame: Month 6, 12, 18 and 24].
- Number of self-reported episodes of severe hypoglycemia [Time frame: Month 6, 12, 18 and 24].
- Percentage of patients not requiring insulin therapy [Time frame: Month 6, 12, 18 and 24]
- Estimated Glucose Disposal Rate (eGDR) [Time frame: Month 6, 12, 18 and 24].
研究者
Enrico Maria Minnelli
Scientific
Dompe' Farmaceutici S.p.A.
研究点 (13)
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