Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664676

Enrollment

Registered

2012-08-14

Start date

2012-12-31

Completion date

2014-02-28

Last updated

2014-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

liraglutide, victoza, GLP-1, kidney, diabetes, renal, diabetic nephropathy

Brief summary

Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against diabetic nephropathy. We hypothesise that this is also the case in humans. This study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2 diabetic patients. Impact on basic kidney physiological will be determined and kidney injury markers will be measured as surrogate parameters of kidney protection.

Interventions

DRUGLiraglutide

DRUGPlacebo-liraglutide

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Informed consent obtained before any trial-related activities. * Male gender * T2DM, diagnosed according to international guidelines * Age 20-60 years, both included * Body Mass Index (BMI): 20-32 kg/m2, both included * Metformin treatment * Albumin/creatinine ratio \<25 mg/mmol

Exclusion criteria

* Known or suspected allergy to trial product or related products * Previous participation in this trial * Previous treatment with GLP-1 analogues or DPP-4 inhibitors * Current treatment with any antidiabetic drug other than metformin * Poorly regulated glycemic control (HbA1c \> 8%) * Impaired kidney function: estimated GFR \< 70ml/min * Impaired liver function: liver parameters exceed 2 times upper normal limit * Subjects with active malignancy * Severe cardiac insufficiency classified according to NYHA III-IV * Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months * Severe, uncontrolled hypertension: sitting blood pressure (BP) \> 180/110 mmHg * Antihypertensive treatment consisting of more than two different pharmaceutical products * Symptoms related to benign prostate hyperplasia * Claustrophobia * Any metal body implants * History of pancreatitis, type 1 diabetes, gastroparesis or multiple endocrine neoplasia syndrome type 2 * Personal or family history of medullary thyroid carcinoma * Any diseases judged by the investigator that could affect the trial * Any medication judged by the investigator that could affect the trial

Design outcomes

Primary

Measure	Time frame
Glomerular Filtration Rate (51Cr-EDTA plasma clearance)	10-15 hours post-dose

Secondary

Measure	Time frame	Description
Renal Blood Flow (functional magnetic resonance imaging)	15 hours post-dose	—
Renal electrolyte clearance	10-15 hours post-dose	Sodium, potassium, calcium, lithium and osmotically active substances.
Excretion of kidney injury markers	0-10 hours and 10-15 hours post-dose	Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.
Plasma concentrations of various hormones	10-15 hours post-dose	Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026