The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure

NCT ID: NCT02284230

Last Updated: 2015-08-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Kidney Failure, Chronic; Prediabetic State

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Liraglutide treatment

Subcutaneous, once daily injection of liraglutide, individually dosed up to 1.8 mg/day.

Group Type: ACTIVE_COMPARATOR

Liraglutide

Intervention Type: DRUG

Placebo treatment

Subcutaneous, once daily injection of placebo, individually dosed up to 1.8 mg/day.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Liraglutide

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Victoza

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

The GCP unit at Copenhagen University Hospital

UNKNOWN

Sponsor Role: collaborator

Bo Feldt-Rasmussen

OTHER

Sponsor Role: lead

Responsible Party

Bo Feldt-Rasmussen

Professor, MD, DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bo Feldt-Rasmussen, Prof,MD,DMSc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Department of Nephrology, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

U1111-1149-7801

Identifier Type: -

Identifier Source: org_study_id