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Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients

NCT ID: NCT01664676

Last Updated: 2014-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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liraglutide victoza GLP-1 kidney diabetes renal diabetic nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Liraglutide

1.2 mg liraglutide sc. (single-dose)

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

Placebo-liraglutide

Placebo liraglutide sc. (single-dose)

Group Type PLACEBO_COMPARATOR

Placebo-liraglutide

Intervention Type DRUG

Interventions

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Liraglutide

Intervention Type DRUG

Placebo-liraglutide

Intervention Type DRUG

Other Intervention Names

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Victoza Isotonic saline

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens S Christiansen, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Department of Endocrinology and Diabetes

Locations

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Aarhus University Hospital, Department of Endocrinology and Diabetes

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2012-003577-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1131-5236

Identifier Type: -

Identifier Source: org_study_id