Status:
WITHDRAWN
The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure
Lead Sponsor:
Bo Feldt-Rasmussen
Collaborating Sponsors:
Novo Nordisk A/S
The GCP unit at Copenhagen University Hospital
Conditions:
Kidney Failure, Chronic
Prediabetic State
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02284230
Start Date
December 1 2014
End Date
August 1 2015
Last Update
August 24 2015
Active Locations (1)
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1
Department of Nephrology, Rigshospitalet
Copenhagen, Denmark, 2100