NCT01664676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

August 10, 2012

Last Update Submit

February 27, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

liraglutidevictozaGLP-1kidneydiabetesrenaldiabetic nephropathy

Outcome Measures

Primary Outcomes (1)

  • Glomerular Filtration Rate (51Cr-EDTA plasma clearance)

    10-15 hours post-dose

Secondary Outcomes (4)

  • Renal Blood Flow (functional magnetic resonance imaging)

    15 hours post-dose

  • Renal electrolyte clearance

    10-15 hours post-dose

  • Excretion of kidney injury markers

    0-10 hours and 10-15 hours post-dose

  • Plasma concentrations of various hormones

    10-15 hours post-dose

Study Arms (2)

Liraglutide

EXPERIMENTAL

1.2 mg liraglutide sc. (single-dose)

Drug: Liraglutide

Placebo-liraglutide

PLACEBO COMPARATOR

Placebo liraglutide sc. (single-dose)

Drug: Placebo-liraglutide

Interventions

LiraglutideDRUG
Also known as: Victoza
Liraglutide
Placebo-liraglutideDRUG
Also known as: Isotonic saline
Placebo-liraglutide

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Endocrinology and Diabetes

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusDiabetic Nephropathies

Interventions

LiraglutideSodium Chloride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jens S Christiansen, Professor

    Aarhus University Hospital, Department of Endocrinology and Diabetes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

December 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

DK(1)