Clinical trial NCT02284230: The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure
Official title: Glycaemic and Cardiovascular Efficacy of Liraglutide in Prediabetic Patients With End-stage Renal Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Kidney Failure, Chronic
Prediabetic State
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: The GCP unit at Copenhagen University Hospital
First posted: 2014-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* The 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

Lawfully detained, institutionalised and patients who are unable to give informed consent due to physical or mental conditions will not be included.

\* Intrauterine devices and hormonal contraceptives (oral pills, patches, implants, vaginal rings, and injections) are considered as adequate contraceptives. Females of childbearing potential must use one of these contraceptives throughout the entire study plus 1 week after last injection with study medication. Surgical sterile (by bilateral vasectomy, tubectomy, hysterectomy or oophorectomy) or postmenopausal (defined as amenorrheic for at least one year) female participants are not considered as having a childbearing potential and are not required to use contraception.

Primary outcomes:
measure: Plasma glucose during oral glucose tolerance test at week 26
timeFrame: The trial visit of week 26
Secondary outcomes:
measure: Hypoglycemic incidents
timeFrame: From the randomisation to trial visit of week 26
measure: Fasting values of glucometabolic hormones
timeFrame: The trial visit of week 26
measure: Insulin resistance
timeFrame: The trial visit of week 26
measure: Beta cell function
timeFrame: The trial visit of week 26
measure: Change in glycemic state
timeFrame: The trial visit of week 26
measure: Blood pressure
timeFrame: The trial visit of week 26
measure: Pulse
timeFrame: The trial visit of week 26
measure: Weight
timeFrame: The trial visit of week 26
measure: Body composition
timeFrame: The trial visit of week 26
measure: Cardiac function and perfusion
timeFrame: The trial visit of week 26
measure: Cardiac autonomic function
timeFrame: The trial visit of week 26
measure: Arterial stiffness
timeFrame: The trial visit of week 26
measure: Cardiovascular and endothelial risk markers
timeFrame: The trial visit of week 26
measure: Prothrombotic state
timeFrame: The trial visit of week 26
measure: Lipid profile
timeFrame: The trial visit of week 26
measure: Plasma liraglutide
timeFrame: The trial visit of week 26
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nephrology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Bo Feldt-Rasmussen, Prof,MD,DMSc
role: PRINCIPAL_INVESTIGATOR
References: