Antiproteinuric Effects of Liraglutide Treatment (LIRALBU)

August 9, 2016 updated by: Peter Rossing, Steno Diabetes Center Copenhagen

Antiproteinuric Effects of Liraglutide Treatment in Patients With Type 2 Diabetes and Albuminuria: A Randomised, Placebo-Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Peter Rossing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liraglutide
Liraglutide s.c. up-escalated to 1.8 mg/day for 12 weeks.
Drug: Liraglutide
active treatment
Other Names:
  • Victoza
PLACEBO_COMPARATOR: Placebo
Placebo s.c. for 12 weeks.
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in albuminuria
Time Frame: 24 weeks
24h urinary albumin excretion rate (UAER mg/24h)
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in renin-angiotensin system hormones
Time Frame: 24 weeks
renin (activity and concentration), angiotensin 1+2, aldosteron (concentrations)
24 weeks
Change in kidney function
Time Frame: 24 weeks
Cr-EDTA-GFR (ml/min/1.73m2)
24 weeks
Change in 24h blood pressure
Time Frame: 24 weeks
24 h systolic and diastolic blood presure (mmHg)
24 weeks
Change in markers of inflammation
Time Frame: 24 weeks
TNF-alfa, mcp (concentration)
24 weeks
24h heart rate
Time Frame: 24 weeks
puls in BPM
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steno Diabetes Center Copenhagen

Collaborators

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (ESTIMATE)

September 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-004502-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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