Antiproteinuric Effects of Liraglutide Treatment

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Collaborator: Novo Nordisk A/S
• Treatments: Liraglutide

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 ≥ 30 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 30 mg/g at screening (measured in at least two of three consecutive morning spot urine samples)

8. Systolic blood pressure (SBP) must be lower than 180 mm Hg at screening.

9. Patients must be on stable glucose lowering medication for at least two weeks before the first visit.

10. Must be able to communicate with the investigator.

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, 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

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

8. 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

9. Previous bowel resection

10. Body mass index <18.5 kg/m2

11. Females of childbearing potential who are pregnant, breast-feeding, intending to become pregnant or not using adequate contraceptive methods

12. Clinical signs of diabetic gastroparesis

13. Impaired liver function (transaminases > two times upper reference levels)

14. The receipt of any investigational product 90 days prior to this trial

15. Known or suspected abuse of alcohol or narcotics

16. Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2