Multi-centre, randomized, double-blind, placebo-controlled, phase II study of SER150TBS in type II diabetic patients.

Phase 1

Active, not recruiting

• Conditions: type II diabetic patients with diabetic nephropathy and albuminuria; MedDRA version: 19.0Level: HLTClassification code 10012658Term: Diabetic complications renalSystem Organ Class: 100000004860; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-003985-25-DE
• Lead Sponsor: Serodus ASA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-20
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Males or females
2. Aged 18 to 85 years, inclusively
3. Female patient is either post-menopausal (presents at least a 12 month period of amenorrhea in women aged = 55 years and two years in those aged < 55 years, and presents / presented clinical signs of menopause: hot flashes, irregular menstrual periods, vaginal drying, sleep disorders, depression and irritability) or surgically sterilized (hysterectomy or bilateral oophorectomy).
4. General good health (ASA class 1 or 2)
5. Well controlled type II diabetes diagnosis
6. Stable antidiabetic treatment (unchanged during the last 3 months, including intensive insulin therapy)
7. Diabetic nephropathy defined either by a positive biopsy or in its absence, by increased urinary albumin excretion in the absence of other renal disease or condition that would explain the albuminuria (for a diabetic patient presenting concomitantly a well-controlled hypertension, a hypertensive nephrosclerosis possibility would not be an exclusion criterion)
8. Albuminuria, either micro (ACR 30-300 mg/g) or macro (ACR >300 mg/g)
9. ALAT, or ASAT values not exceeding 1.5x ULN
10. ALP, PT (or its international normalized ratio (INR)) and bilirubin within normal values
11. eGFR equal or above 30 ml/min (CKD-Epi-formula)
12. Glycated haemoglobin (HbA1c) = 7.5%. A HbA1c value up to 8.5 % is acceptable in well controlled patients (according to the investigator’s opinion), particularly in elderly patients
13. Normal blood pressure or well controlled hypertension (maximum 140 mm Hg systolic and 90 mm Hg diastolic)

Ethical/Other:
14. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.

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 47
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47

Exclusion Criteria

1. Recent history or ongoing liver disease, including viral infections (Hepatitis A/B/C/D/E, Coxsackie, or other viral infections of the liver)
2. ALAT or, ASAT values exceeding 1.5x ULN
3. ALP, PT (or its international normalized ratio (INR)) or bilirubin values exceeding the ULN
4. Stroke within the last 3 months
5. Systemic infections during the last month
6. Severe renal failure (eGFR under 30 ml/min, CKD-Epi-formula)
7. Chronic treatment with non-steroidal anti-inflammatory drugs (NSAID) including regular dose aspirin. Low dose aspirin treatment up to 100 mg/d is allowed.
8. Any bleeding disorder or acute blood coagulation defect
9. A history of gastric ulcers or any other organic lesion susceptible to bleeding
10. Subjects who have undergone any kind of surgery in the last 2 weeks before IMP/placebo administration
11. Others: allergy to the active substance or any of the excipients of the IMP
12. Pregnant or lactating women
13. Only for participation in the second cohort: Patients having participated in the first cohort
14. Present participation in another clinical study or having participated in a clinical study requiring the administration of an investigational medicine, 6 months prior to enrolment (i.e. no interaction with the previous investigational medicine should be possible)
15. History of serious cardiac disease, defined as myocardial infarction within three months of inclusion, congestive heart failure classified by the New York Heart Association as Class III or IV, poorly controlled or unstable angina, electrocardiographic evidence of acute ischemia, or clinically significant cardiac arrhythmias (i.e. the patient should have no symptoms and need no specific treatment, or have an appropriate treatment with successful control)
Ethical/Other:
16. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
17. Subjects dependent on the sponsor, investigators, personnel of the trial site or any other individual whose willingness to volunteer may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified