A Clinical Study to evaluate Ladarixin as an additional therapy to improve glycemic control in overweight insulin resistance patients with type 1 diabetes.
- Conditions
- overweight insulin-resistant patients with type 1 diabetesMedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2022-000743-68-IT
- Lead Sponsor
- DOMPé FARMACEUTICI S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 86
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method