Type 1 diabetes MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Ursofalk 500mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - T1DM patients aged 20 to 75 years, with residual albuminuria (defined as an urine albumin to creatinine ratio >3 mg/mmol) or proteinuria in the preceding 6 months on a maximum tolerated and stable dose of RAAS blockade (ACE-inhibitor or angiotensin receptor blocker-ARB). - Estimated GFR (by MDRD equation) =30 ml/min. - Written informed consent to participate in the study prior to any study procedures. - Ability to communicate and comply with all study requirements. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - History of intolerance to Ursodeoxycholic acid. - Active gastrointestinal disease (such as gall stones, inflammatory bowel disease, primary sclerosing cholangitis). - Non-diabetic renal disease. - Absence of diabetic retinopathy (as this would suggest non diabetic renal disease). - Pregnancy. - Insufficient understanding of the trial - Lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if Ursodeoxycholic acid reduces albuminuria in patients with type 1 diabetes mellitus (T1DM) with residual albuminuria despite established standard care. ;Secondary Objective: To evaluate if Ursodeoxycholic acid improves n vascular , metabolic and renal measures / function excretion ;Primary end point(s): Change in albumin excretion rate (AER) after 24 weeks treatment with Ursodeoxycholic acid as compared to 24 weeks on placebo;Timepoint(s) of evaluation of this end point: After 24 and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in endothelial function and permeability Change in serum electrolytes (sodium, potassium), and renal function/estimated GFR Change in brachial blood pressure. Change in central aortic blood pressure and Ao-PWV. Change in HbA1c, lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides). Change in plasma albumin and liver function tests (ALT, ALP GGT). Change in 24 hours urine sodium, urine magnesium, uric acid, calcium and phosphate, potassium excretion. Change in endothelial and renal injury markers; hsCRP, VCAM, ET-1, vWF, oxLDL, Interleukin 6, Interleukin 1-beta, Interleukin 18, NGAL, KIM-1 and LFABP. Change in levels of circulating serum levels of Ursodeoxycholic acid and other bile acids (including cholic acid,deoxycholicacid, chenodeoxycholic acid, lithocholic acid) ;Timepoint(s) of evaluation of this end point: 48 weeks | — |
Countries
United Kingdom
Contacts
Public ContactDr Janaka Karalliedde
King's College London
Outcome results
None listed