iraglutide Kidney:A study investigating the short-term impact of liraglutide on kidney function in diabetic patients

Phase 1

• Conditions: Type 2 diabetes mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-003577-26-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-26
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.
Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2.
Male gender
3.
T2DM, diagnosed according to international guidelines
4.
Age 20-60 years, both included
5.
Body Mass Index (BMI): 20-32 kg/m2, both included
6.
Metformin treatment
7.
Albumin/creatinine ratio < 25 mg/mmol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.
Known or suspected allergy to trial product or related products
2.
Previous participation in this trial
3.
Previous treatment with GLP-1 analogues or DPP-4 inhibitors
4.
Current treatment with any antidiabetic drug other than metformin
5.
Poorly regulated glycemic control (HbA1c > 8%)
6.
Impaired kidney function: estimated GFR < 70ml/min (estimated from creatinine concentration)
7.
Impaired liver function: liver parameters exceed 2 times or more the upper normal limit, according to the hospital lab
8.
Subjects with active malignancy
9.
Severe cardiac insufficiency classified according to NYHA III-IV
10.
Unstable angina pectoris, acute myocardial infarction (AMI) within the last 12 months
11.
Severe, uncontrolled hypertension: sitting blood pressure (BP) > 180/110 mmHg
12.
Antihypertensive treatment consisting of more than two different pharmaceutical products
13.
Symptoms related to benign prostate hyperplasia
14.
Claustrophobia
15.
Any metal body implants
16.
History of pancreatitis, type 1 diabetes, gastroparesis or multiple endocrine neoplasia syndrome type 2
17.
Personal or family history of medullary thyroid carcinoma
18.
Any diseases judged by the investigator that could affect the trial
19.
Any medication judged by the investigator that could affect the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified