A study to investigate the mechanism of action and safety of Epeleuton capsules in the treatment of patients with type 2 diabetes and diabetic complications
- Conditions
- Type 2 diabetes and diabetic complicationsMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: HLGTClassification code 10012653Term: Diabetic complicationsSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2020-002911-23-DE
- Lead Sponsor
- Afimmune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
1. Patients diagnosed with type 2 diabetes mellitus at least 90 days prior to the first screening visit.
2. Patients with a HbA1C (glycosylated haemoglobin) between 7.0-10.0% (53-85.8 mmol/mol) (both inclusive)
3. Patients with a fasting triglyceride level =120 mg/dL and <250mg/dL at the screening visit.
Note: If the triglyceride level is outside the required range at the second screening visit, an additional measurement can be obtained 1 week later, to confirm eligibility.
4. Patients with a clinical diagnosis of diabetic peripheral neuropathy.
5. Patients who have been educated regarding diet and exercise at or before visit 1 (screening 1) and are willing to maintain and not alter a stable diet and activity routine throughout the study.
6. Patients who have been on a stable statin therapy at doses that are likely to achieve optimal LDL cholesterol and who are willing to continue this treatment throughout the study.
7. Patients who have a BMI = 25kg/m2 and <45kg/m2.
8. Patients who have been on a stable daily dose of metformin (at least 1500mg or maximum tolerated dose for metformin monotherapy as documented in the patient medical record) and/or a sulfonylurea and/or a DPP-4 inhibitor and/or a SGLT2i and/or insulin for at least 90 days prior to the day of first screening visit.
Note: Permitted insulin therapy does not include short-term insulin treatment for acute illness
9. Female patients and male patients with female partners of childbearing potential must use highly effective birth control methods or have a sterilised partner for the duration of the study. Highly effective birth control methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include intrauterine device or sexual abstinence.
Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Note: Hormonal contraceptives must be on a stable dose for at least one month before baseline.
Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
10. Patients whose pre-study or screening clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator, and do not violate any inclusion or exclusion criteria
11. Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
12. Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent prior to initiation of any study specific activities or procedures.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Patients who have a history of intolerance or hypersensitivity to any substance in Epeleuton capsules, placebo capsules, statins, metformin, sulfonylureas, DPP-4 inhibitors or SGLT2i.
2. Patients with uncontrolled hypertension defined as a systolic blood pressure =160 mmHg or a diastolic blood pressure =100mmHg.
3. Patients who have a BMI <25kg/m2 or = 45kg/m2.
4. Patients who have a weight change >2kg from the first screening visit to the baseline visit.
5. Patients who have type 1 diabetes mellitus.
6. Patients who have thyroid stimulating hormone (TSH) levels >1.5 times the upper limit of normal.
7. Patients with significant liver disease or liver function impairment defined as any of the following; cirrhosis, hepatitis, biliary obstruction with hyperbilirubinemia (total bilirubin >2 times the upper limit of normal) and aspartate aminotransferase (AST) or alanine aminotransferase levels (ALT) >3 times the upper limit of normal.
8. Patients with stage 4 or stage 5 chronic kidney disease (CKD) defined as an estimated glomerular filtration rate <30 mL/min/1.73m2 as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
9. Patients with a history of malignancies within the past five years other than curatively treated non-melanoma skin cancer (basal cell or squamous cell carcinomas).
10. Patients who have been treated with any investigational product within 60 days prior to visit 1 (screening 1), or five half-lives (whichever is longer). Patients cannot participate in any other investigational medication or medical device trial while participating in this study.
11. Patients who have used dietary supplements or prescription products rich in omega-3 or omega-6 fatty acids in the four weeks prior to baseline.
12. Patients who have been treated with any medication for diabetes or obesity in the four weeks before the baseline visit, except for metformin, sulfonylureas, DPP-4 inhibitors, SGLT2i and short-term insulin treatment for acute illness for a total of below or equal to 14 days.
13. Patients who have been treated with fibrates, ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, bile acid sequestrants, niacin, niacin analogues or dietary supplements for the purpose of lowering triglycerides or cholesterol in the six weeks prior to baseline.
14. Patients who have been treated with anti-psychotic medications in the six weeks prior to baseline.
15. Patients who have a family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinomas.
16. Patients who have chronic pancreatitis.
17. Patients who have a history of major surgical procedures involving the stomach potentially affecting absorption of investigational medicinal product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
18. Patients who have planned major surgical procedures, coronary intervention (such as stent placement or heart bypass), carotid or peripheral revascularisation.
19. Patients who have a history of myocardial infarction, stroke, coronary revascularisation or hospitalisation for unstable angina in the three months prior to screening.
20. Patients with unexplained creatine kinase concentrations > 10 times the upper limit of normal or creatine kinase elevation due to known muscle disease at visit 1 (screening 1)
21. Patients who are classified as being in New York Heart Association (NYHA) Class IV.
22. Patients who have a history of diabetic ketoacidosis.
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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