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Antiproteinuric Effects of Liraglutide Treatment (LIRALBU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02545738
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : August 10, 2016
Novo Nordisk A/S
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center Copenhagen

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

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Liraglutide Drug: placebo Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antiproteinuric Effects of Liraglutide Treatment in Patients With Type 2 Diabetes and Albuminuria: A Randomised, Placebo-Controlled Trial
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide
Liraglutide s.c. up-escalated to 1.8 mg/day for 12 weeks.
Drug: Liraglutide
active treatment
Other Name: Victoza

Placebo Comparator: Placebo
Placebo s.c. for 12 weeks.
Drug: placebo

Primary Outcome Measures :
  1. Change in albuminuria [ Time Frame: 24 weeks ]
    24h urinary albumin excretion rate (UAER mg/24h)

Secondary Outcome Measures :
  1. Change in renin-angiotensin system hormones [ Time Frame: 24 weeks ]
    renin (activity and concentration), angiotensin 1+2, aldosteron (concentrations)

  2. Change in kidney function [ Time Frame: 24 weeks ]
    Cr-EDTA-GFR (ml/min/1.73m2)

  3. Change in 24h blood pressure [ Time Frame: 24 weeks ]
    24 h systolic and diastolic blood presure (mmHg)

  4. Change in markers of inflammation [ Time Frame: 24 weeks ]
    TNF-alfa, mcp (concentration)

  5. 24h heart rate [ Time Frame: 24 weeks ]
    puls in BPM

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02545738

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Peter Rossing
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Novo Nordisk A/S
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Principal Investigator: Peter Rossing, MD Steno Diabetes Center Copenhagen

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Peter Rossing, Professor, Steno Diabetes Center Copenhagen Identifier: NCT02545738    
Other Study ID Numbers: 2014-004502-15
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists