Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Liraglutide; Drug: Placebo-liraglutide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01664676

2012-003577-26 (EudraCT Number)

U1111-1131-5236

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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11 participants in 2 patient groups, including a placebo group

Liraglutide

Experimental group

Description:

1.2 mg liraglutide sc. (single-dose)

Treatment:

Drug: Liraglutide

Placebo-liraglutide

Placebo Comparator group

Description:

Placebo liraglutide sc. (single-dose)

Treatment:

Drug: Placebo-liraglutide