EUCTR2014-001778-32-DK
Active, not recruiting
Not Applicable
Glycaemic and cardiovascular efficacy of liraglutide in prediabetic patients with end-stage renal disease - The LiRA2 study
Bo Feldt-Rasmussen0 sitesJune 17, 2014
ConditionsPrediabetes and dialysis dependent end-stage renal diseaseMedDRA version: 17.0Level: LLTClassification code 10014646Term: End stage renal disease (ESRD)System Organ Class: 100000004857MedDRA version: 17.0Level: LLTClassification code 10065542Term: PrediabetesSystem Organ Class: 100000004861MedDRA version: 17.0Level: LLTClassification code 10012347Term: Dependence on renal dialysisSystem Organ Class: 100000004869Therapeutic area: Not possible to specify
DrugsVictoza
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prediabetes and dialysis dependent end-stage renal disease
- Sponsor
- Bo Feldt-Rasmussen
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female; age: 18 \- 85 years
- •End\-stage renal diasease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis)
- •Impaired glucose tolerance (2h plasma glucose \= 7,8 and \< 11\.1 mmol/l following a 75g\-OGTT) and/or impaired fasting glucose (fasting plasma glucose \= 6\.1 and \< 7\.0 mmol/l) evaluated at the screening visit
- •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 20
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •Diabetes mellitus type 1 or type 2 (diagnose according to WHO criteria)
- •Chronic pancreatitis / previous acute pancreatitis
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Treatment with oral glucocorticoids, calcineurin inhibitors or incretin\-based therapy 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 investigator’s opinion could interfere with the results of the trial
- •Clinical suspicion of cardiac disease currently investigated
- •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 (BMI) \<20 kg/m2 and/or \>50 kg/m2
- •Females of childbearing potential who are pregnant, breast\-feeding, intend to become pregnant or are not using adequate contraceptive methods\*
- •Impaired liver function (transaminases \> two times upper reference levels)
Outcomes
Primary Outcomes
Not specified
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