Glycaemic and Cardiovascular Efficacy of Liraglutide in Prediabetic Patients With End-stage Renal Disease
Overview
- Phase
- Phase 2
- Intervention
- Liraglutide
- Conditions
- Kidney Failure, Chronic
- Sponsor
- Bo Feldt-Rasmussen
- Locations
- 1
- Primary Endpoint
- Plasma glucose during oral glucose tolerance test at week 26
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD). The primary objective is to determine the efficacy of the treatment on glucose tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives include various clinical and biochemical cardiovascular and safety parameters.
We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate other cardiovascular risk factors.
Investigators
Bo Feldt-Rasmussen
Professor, MD, DMSc
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •End-stage renal disease 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
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)
Arms & Interventions
Liraglutide treatment
Subcutaneous, once daily injection of liraglutide, individually dosed up to 1.8 mg/day.
Intervention: Liraglutide
Placebo treatment
Subcutaneous, once daily injection of placebo, individually dosed up to 1.8 mg/day.
Intervention: Placebo
Outcomes
Primary Outcomes
Plasma glucose during oral glucose tolerance test at week 26
Time Frame: The trial visit of week 26
Difference between the two treatment arms in plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26
Secondary Outcomes
- Cardiac autonomic function(The trial visit of week 26)
- Lipid profile(The trial visit of week 26)
- Fasting values of glucometabolic hormones(The trial visit of week 26)
- Blood pressure(The trial visit of week 26)
- Pulse(The trial visit of week 26)
- Weight(The trial visit of week 26)
- Hypoglycemic incidents(From the randomisation to trial visit of week 26)
- Change in glycemic state(The trial visit of week 26)
- Insulin resistance(The trial visit of week 26)
- Beta cell function(The trial visit of week 26)
- Body composition(The trial visit of week 26)
- Arterial stiffness(The trial visit of week 26)
- Cardiac function and perfusion(The trial visit of week 26)
- Cardiovascular and endothelial risk markers(The trial visit of week 26)
- Prothrombotic state(The trial visit of week 26)
- Plasma liraglutide(The trial visit of week 26)