Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients
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ClinicalTrials.gov Identifier: NCT01664676 |
Recruitment Status
:
Completed
First Posted
: August 14, 2012
Last Update Posted
: February 28, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: Liraglutide Drug: Placebo-liraglutide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Liraglutide
1.2 mg liraglutide sc. (single-dose)
|
Drug: Liraglutide
Other Name: Victoza
|
Placebo Comparator: Placebo-liraglutide
Placebo liraglutide sc. (single-dose)
|
Drug: Placebo-liraglutide
Other Name: Isotonic saline
|
- Glomerular Filtration Rate (51Cr-EDTA plasma clearance) [ Time Frame: 10-15 hours post-dose ]
- Renal Blood Flow (functional magnetic resonance imaging) [ Time Frame: 15 hours post-dose ]
- Renal electrolyte clearance [ Time Frame: 10-15 hours post-dose ]Sodium, potassium, calcium, lithium and osmotically active substances.
- Excretion of kidney injury markers [ Time Frame: 0-10 hours and 10-15 hours post-dose ]Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.
- Plasma concentrations of various hormones [ Time Frame: 10-15 hours post-dose ]Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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): NCT01664676
Denmark | |
Aarhus University Hospital, Department of Endocrinology and Diabetes | |
Aarhus, Denmark, 8000 |
Principal Investigator: | Jens S Christiansen, Professor | Aarhus University Hospital, Department of Endocrinology and Diabetes |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT01664676 History of Changes |
Other Study ID Numbers: |
U1111-1131-5236 2012-003577-26 ( EudraCT Number ) |
First Posted: | August 14, 2012 Key Record Dates |
Last Update Posted: | February 28, 2014 |
Last Verified: | February 2014 |
Keywords provided by University of Aarhus:
liraglutide victoza GLP-1 kidney |
diabetes renal diabetic nephropathy |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Liraglutide |
Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |