Type 2 Diabetes MellitusPhase 4NCT01664676
Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients
A Phase 4 study testing Liraglutide in people with Type 2 Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Liraglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Endocrinology and Diabetes
Aarhus, 8000
About this study
Official title: A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Liraglutide, Placebo-liraglutide
- Keywords
- liraglutide, victoza, GLP-1, kidney, diabetes, renal, diabetic nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
Placebo-liraglutideDrug
Also called Isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | 1.2 mg liraglutide sc. (single-dose) Receives: Drug: Liraglutide |
| Placebo-liraglutide | Placebo comparator | Placebo liraglutide sc. (single-dose) Receives: Drug: Placebo-liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate (51Cr-EDTA plasma clearance)
Measured: 10-15 hours post-dose
Secondary outcomes (4)
Renal Blood Flow (functional magnetic resonance imaging)
Measured: 15 hours post-dose
Renal electrolyte clearance
Sodium, potassium, calcium, lithium and osmotically active substances.
Measured: 10-15 hours post-dose
Excretion of kidney injury markers
Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.
Measured: 0-10 hours and 10-15 hours post-dose
Plasma concentrations of various hormones
Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.
Measured: 10-15 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Jens S Christiansen, Professor, Principal investigator, Aarhus University Hospital, Department of Endocrinology and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664676
- Sponsor's protocol ID
- U1111-1131-5236
- Other IDs
- 2012-003577-26
- Status last verified
- Feb 2014
- First submitted
- 10 Aug 2012
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01664676
- Acronym / sponsor ID
- U1111-1131-5236
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- liraglutide, victoza, GLP-1, kidney, diabetes, renal, diabetic nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, University of Copenhagen
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: Liraglutide1.2 mg liraglutide sc. (single-dose) |
| Placebo-liraglutide | Placebo comparator | Drug: Placebo-liraglutidePlacebo liraglutide sc. (single-dose) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: Victoza | Drug | Liraglutide |
| Placebo-liraglutideAlso: Isotonic saline | Drug | Placebo-liraglutide |
Primary outcome
Glomerular Filtration Rate (51Cr-EDTA plasma clearance)
Time frame: 10-15 hours post-dose
4 secondary outcomes
Renal Blood Flow (functional magnetic resonance imaging)
Time frame: 15 hours post-dose
Renal electrolyte clearance
Time frame: 10-15 hours post-dose
Excretion of kidney injury markers
Time frame: 0-10 hours and 10-15 hours post-dose
Plasma concentrations of various hormones
Time frame: 10-15 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens S Christiansen, Professor principal investigator
Aarhus University Hospital, Department of Endocrinology and Diabetes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with Type 2 Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Filtration Rate (51Cr-EDTA plasma clearance) (time frame: 10-15 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.