Antiproteinuric Effects of Liraglutide Treatment (LIRALBU)

Steno Diabetes Centers

Status and phase

Completed

Phase 4

Conditions

Diabetic Kidney Disease

Treatments

Drug: placebo

Drug: Liraglutide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02545738

2014-004502-15

Details and patient eligibility

About

The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2 diabetes.

Full description

Initial findings point to a clinically significant antiproteinuric effect of liraglutide treatment, possibly independent from blood pressure reduction. The mechanism behind is unclear and the magnitude of albuminuria reduction needs to be verified. Antiproteinuric effects are usually renoprotective and potentially also cardioprotective and may suggest an additional benefit from liraglutide treatment.

The aim of this study is to evaluate the magnitude of the antiproteinuric effect of short-term liraglutide treatment (12 weeks) in patients with type 2 diabetes and albuminuria. In addition, possible mechanisms causing the antiproteinuric effect will be explored.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee
Male or female patients >18 years with type 2 diabetes (WHO criteria).
HbA1c ≥ 48 mmol/mol (6.5 %)
eGFR ≥ 30 ml/min/1.73 m2 (estimated by MDRD formula)
Fertile female patients must use chemical, hormonal or mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomi or have been surgically sterilized or hysterectomised at least six months prior to screening
Patients must be on stable RAAS-blocking treatment (unchanged dose 4 weeks before inclusion)
Geometic mean urine albumin-to-creatinine ratio (UACR) above 30 mg/g at screening (measured in at least two of three consecutive morning spot urine samples)
Systolic blood pressure (SBP) must be lower than 180 mm Hg at screening.
Patients must be on stable glucose lowering medication for at least two weeks before the first visit.
Must be able to communicate with the investigator.

Exclusion criteria

SBP > 180 mm Hg at screening
Type 1 diabetes mellitus
Chronic pancreatitis / previous acute pancreatitis
Known or suspected hypersensitivity to trial product(s) or related products.
Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon like peptide-1 agonists and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, 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, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
Inflammatory bowel disease
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
Previous bowel resection
Body mass index <18.5 kg/m2
Females of childbearing potential who are pregnant, breast-feeding, intending to become pregnant or not using adequate contraceptive methods
Clinical signs of diabetic gastroparesis
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
Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2