Safety and effect of treatment with the antidiabetic drug liraglutide in patients with type 2 diabetes and severely impaired kidney functio

Phase 1

• Conditions: 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: 14.1Level: LLTClassification code 10012347Term: Dependence on renal dialysisSystem Organ Class: 10041244 - Social circumstances; MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-021922-36-DK
• Lead Sponsor: Department of Nephrology, Rigshospitalet, University of Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-02
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

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

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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