Albuminuria. Diabetic nephropathy. MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Steno Diabetes Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 2. Male or female patients >18 years with type 2 diabetes (WHO criteria). 3. HbA1c = 48 mmol/mol (6.5 %) 4. eGFR = 45 ml/min/1.73 m2 (estimated by MDRD formula) 5. 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 6. Patients must be on stable RAAS-blocking treatment (unchanged dose 4 weeks before inclusion) 7. Geometic mean urine albumin-to-creatinine ratio (UACR) above 100 mg/g at screening (measured in at least two of three consecutive morning spot urine samples) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. SBP > 180 mm Hg at screening 2. Type 1 diabetes mellitus 3. Chronic pancreatitis / previous acute pancreatitis 4. Known or suspected hypersensitivity to trial product(s) or related products. 5. Treatment with oral glucocorticoids, calcineurin inhibitors, or dipeptidyl peptidase 4 (DPP4) inhibitors which in the investigator’s opinion could interfere with glucose or lipid metabolism 90 days prior to screening 6. 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 7. Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Possible mechanisms causing the antiproteinuric effect will be explored. ;Primary end point(s): • Change in albuminuria;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in renin-angiotensin system hormones • Change in markers of inflammation • Change in kidney function • Change in 24hour blood pressure and heart rate;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Denmark
Contacts
Public ContactSteno Diabetes Center
Steno Diabetes Center
Outcome results
None listed