The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 31 August 2015
• Main ID: NCT02284230
• Date of registration: 03/11/2014
• Prospective Registration: Yes
• Primary sponsor: Bo Feldt-Rasmussen
• Public title: The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure LiRA2
• Scientific title: Glycaemic and Cardiovascular Efficacy of Liraglutide in Prediabetic Patients With End-stage Renal Disease
• Date of first enrolment: December 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02284230
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Bo Feldt-Rasmussen, Prof,MD,DMSc
• Affiliation: Rigshospitalet, Denmark

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Failure, Chronic

Prediabetic State

Intervention(s)

Drug: Liraglutide

Drug: Placebo

Primary Outcome(s)

Plasma glucose during oral glucose tolerance test at week 26 [Time Frame: The trial visit of week 26]

Secondary Outcome(s)

Beta cell function [Time Frame: The trial visit of week 26]

Plasma liraglutide [Time Frame: The trial visit of week 26]

Cardiac function and perfusion [Time Frame: The trial visit of week 26]

Weight [Time Frame: The trial visit of week 26]

Change in glycemic state [Time Frame: The trial visit of week 26]

Pulse [Time Frame: The trial visit of week 26]

Body composition [Time Frame: The trial visit of week 26]

Cardiac autonomic function [Time Frame: The trial visit of week 26]

Arterial stiffness [Time Frame: The trial visit of week 26]

Cardiovascular and endothelial risk markers [Time Frame: The trial visit of week 26]

Fasting values of glucometabolic hormones [Time Frame: The trial visit of week 26]

Prothrombotic state [Time Frame: The trial visit of week 26]

Hypoglycemic incidents [Time Frame: From the randomisation to trial visit of week 26]

Blood pressure [Time Frame: The trial visit of week 26]

Insulin resistance [Time Frame: The trial visit of week 26]

Lipid profile [Time Frame: The trial visit of week 26]

Secondary ID(s)

U1111-1149-7801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The GCP unit at Copenhagen University Hospital

Novo Nordisk A/S