1) Patients with type 2 diabetes (T2D) and no or severely reduced kidney function, depending on chronic dialysis treatment. 2) Patients with T2D and normal kidney function. MedDRA version: 14.1 Level: LLT Classification code 10012347 Term: Dependence on renal dialysis System Organ Class: 10041244 - Social circumstances MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 1
Conditions
Interventions
Trade Name: Victoza®
Product Name: Liraglutide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
Department of Nephrology, Rigshospitalet, University of Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group 1) · Male or female; aged 18-85 years · Chronic severely impaired kidney function treated with chronic maintenance dialysis · Type 2 Diabetes Group 2) · Male or female; aged 18-85 years · Normal kidney fuction · Type 2 Diabetes Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Group 1 and 2 · Type 1 diabetes mellitus · Chronic pancreatitis / previous acute pancreatitis · Known or suspected hypersensitivity to trial product(s) or related products · Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, which in the Investigator’s opinion could interfere with glucose or lipid metabolism 90 days prior to screening · Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder which in the investigators’ opinion could interfere with the results of the trial · Inflammatory bowel disease · Cardiac disease defined as: decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months · Body mass index = 18.5 kg/m2 or = 50.0 kg/m2 · Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods · Clinical signs of diabetic gastroparesis · Impaired liver function (transaminases >two times upper reference levels) · Receipt of any investigational product 90 days prior to this trial · Known or suspected abuse of alcohol or narcotics · Screening calcitonin =50 ng/l · Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate safety parameters in patients with T2D and no or severely reduced kidney function treated with the antidiabetig drug liraglutide. Plasma concentrations of liraglutide and side effects will be closely monitored during intervention. Results will be compared with a group of patients with T2D and normal kidney function.;Secondary Objective: To investigate efficacy parameters in patients with diabetes and no or severely reduced kidney function treated with the antidiabetig drug liraglutide. Regulation of blood glucose, weight and cardiovascular parameters will be monitored.;Primary end point(s): The primary endpoint is the trough concentrations of liraglutide over time. It will be compared between patients with normal kidney function and patients in dialysis to evaluate the level of accumulation of liraglutide in patients undergoing dialysis treatment.;Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoint is expected after LPLV, ie ultimo 2013 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PD parameters: - Postprandial plasma glucose, assessed by mean and peak PG values and AUC during a standard 4-hour meal test before and after intervention (optionel to dialysis patients). - HbA1c, FPG; Body weight, Beta-cell surrogate markers, lipids, and other cardiovascular risk markers (ProBNP, CRP, vWF). Safety of liraglutide will be evaluated by registration of - AE´s - Hypoglycaemic events divided into minor (BG<3.1 mM, and no need for assistance) or major (requiring assistance from third person). Registered by measurements from the CONTOUR® USB apparatus and questioning during trial visits. The comparison of safety parameters will be performed both between active vs. placebo group of renal impaired patients, as well as between the two active liraglutide groups. - Plasma concentration of liraglutide pre-, per- and post dialysis treatment (PD and HD). - Concentration of liraglutide in dialysis fluid (PD and HD). Other secondary endpoints - Glycaemic control (assessed from 24-hour glucose profile, daily blood glucose measurements and HbA1c before, during and after intervention). - Pancreatic beta-cell function (assessed from results of meal test before and after intervention and/or proinsulin-insulin ratio). - Liver- and kidney function and homeostasis (blood samples before and after intervention) - Cardiovascular parameters: Blood pressure, ECG, lipid profile and proBNP before and after intervention - Markers of inflammation and endothelial function: vWF, CRP - Insulin dose among participants treated with insulin at start of intervention - Dose of oral antidiabetics among participants treated with oral antidiabetics at start of intervention - Weight ;Timepoint(s) of evaluation of this end point: Evaluation of the secondary endpoints is expected after LPLV, ie ultimo 2013 | — |
Countries
Denmark
Contacts
Public ContactBo Feldt-Rasmussen
Department of Nephrology
Outcome results
None listed