Antiproteinuric Effects of Liraglutide Treatment (LIRALBU)
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|ClinicalTrials.gov Identifier: NCT02545738|
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Kidney Disease||Drug: Liraglutide Drug: placebo||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Liraglutide s.c. up-escalated to 1.8 mg/day for 12 weeks.
Other Name: Victoza
Placebo Comparator: Placebo
Placebo s.c. for 12 weeks.
- Change in albuminuria [ Time Frame: 24 weeks ]24h urinary albumin excretion rate (UAER mg/24h)
- Change in renin-angiotensin system hormones [ Time Frame: 24 weeks ]renin (activity and concentration), angiotensin 1+2, aldosteron (concentrations)
- Change in kidney function [ Time Frame: 24 weeks ]Cr-EDTA-GFR (ml/min/1.73m2)
- Change in 24h blood pressure [ Time Frame: 24 weeks ]24 h systolic and diastolic blood presure (mmHg)
- Change in markers of inflammation [ Time Frame: 24 weeks ]TNF-alfa, mcp (concentration)
- 24h heart rate [ Time Frame: 24 weeks ]puls in BPM
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 ClinicalTrials.gov identifier (NCT number): NCT02545738
|Gentofte, Denmark, 2820|
|Principal Investigator:||Peter Rossing, MD||Steno Diabetes Center Copenhagen|