Kidney Failure, ChronicPhase 2LiRA2NCT02284230
The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure
A Phase 2 study testing Liraglutide in people with Kidney Failure, Chronic and Prediabetic State, run by Bo Feldt-Rasmussen at 1 site in Denmark.
Trial summary
The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Kidney Failure, Chronic, Prediabetic State
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Aug 2015
- Phase
- Phase 2
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage renal disease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis)
- Impaired glucose tolerance (2h plasma glucose ≥ 7,8 and < 11.1 mmol/l following a 75g-OGTT) and/or impaired fasting glucose (fasting plasma glucose ≥ 6.1 and < 7.0 mmol/l) evaluated at the screening visit
Who cannot join
- Diabetes mellitus type 1 or type 2 (diagnose according to WHO criteria)
- Chronic pancreatitis / previous acute pancreatitis
- Known or suspected hypersensitivity to trial product(s) or related products
- Treatment with oral glucocorticoids, calcineurin inhibitors or incretin-based therapy which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
- Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the investigator's opinion could interfere with the results of the trial
- Clinical suspicion of cardiac disease currently investigated
Show all 16Show fewer
- Cardiac disease defined as: decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
- Body mass index (BMI) <20 kg/m2 and/or >50 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods*
- Impaired liver function (transaminases > two times upper reference levels)
- The receipt of any investigational product 90 days prior to this trial
- Known or suspected abuse of alcohol or narcotics
- Screening calcitonin ≥ 50 ng/l
- Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
- Lawfully detained, institutionalised and patients who are unable to give informed consent due to physical or mental conditions will not be included.
- Intrauterine devices and hormonal contraceptives (oral pills, patches, implants, vaginal rings, and injections) are considered as adequate contraceptives. Females of childbearing potential must use one of these contraceptives throughout the entire study plus 1 week after last injection with study medication. Surgical sterile (by bilateral vasectomy, tubectomy, hysterectomy or oophorectomy) or postmenopausal (defined as amenorrheic for at least one year) female participants are not considered as having a childbearing potential and are not required to use contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycaemic and Cardiovascular Efficacy of Liraglutide in Prediabetic Patients With End-stage Renal Disease
The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD). The primary objective is to determine the efficacy of the treatment on glucose tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives include various clinical and biochemical cardiovascular and safety parameters.
We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate other cardiovascular risk factors.
- Conditions
- Kidney Failure, Chronic, Prediabetic State
- Being tested
- Liraglutide, Placebo
- Medical subject headings
- Kidney Failure, Chronic, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide treatment | Active comparator | Subcutaneous, once daily injection of liraglutide, individually dosed up to 1.8 mg/day. Receives: Drug: Liraglutide |
| Placebo treatment | Placebo comparator | Subcutaneous, once daily injection of placebo, individually dosed up to 1.8 mg/day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose during oral glucose tolerance test at week 26
Difference between the two treatment arms in plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26
Measured: The trial visit of week 26
Secondary outcomes (16)
Hypoglycemic incidents
Total hypoglycemic episodes during intervention
Measured: From the randomisation to trial visit of week 26
Fasting values of glucometabolic hormones
Fasting plasma glucose, proinsulin, insulin and glucagon
Measured: The trial visit of week 26
Insulin resistance
Insulin resistance evaluated by homeostasis model assessment (HOMA)
Measured: The trial visit of week 26
Beta cell function
Beta-cell function evaluated by HOMA
Measured: The trial visit of week 26
Change in glycemic state
Change in glycemic state following oral glucose tolerance test (normal glucose tolerance (NGT, fasting plasma glucose < 6.1 mmol/l and 2h plasma glucose < 7.8 mmol/l), impaired fasting glucose (IFG, fasting plasma glucose ≥ 6.1 and < 7.0 mmol/l), impaired glucose tolerance (IGT, 2h plasma glucose ≥ 7,8 and < 11.1 mmol/l) and diabetes mellitus (DM, fasting plasma glucose ≥ 7 mmol/l or 2h plasma glucose ≥ 11.1 mmol/l))
Measured: The trial visit of week 26
Blood pressure
Blood Pressure
Measured: The trial visit of week 26
Pulse
Resting pulse
Measured: The trial visit of week 26
Weight
Weight
Measured: The trial visit of week 26
Body composition
Body composition by dual energy x-ray absorptiometry (DXA) scan
Measured: The trial visit of week 26
Cardiac function and perfusion
Cardiac function and perfusion evaluated by Rb-PET/CT scan
Measured: The trial visit of week 26
Cardiac autonomic function
Cardiac autonomic function evaluated by heart rate variability
Measured: The trial visit of week 26
Arterial stiffness
Arterial stiffness evaluated by Augmentation index from Pulse wave analysis
Measured: The trial visit of week 26
Cardiovascular and endothelial risk markers
Cardiovascular and endothelial risk markers (troponin T, troponin I, creatine kinase-MB, high-sensitivity C-reactive protein (hsCRP), plasminogen activator inhibitor 1 (PAI-1), Tissue plasminogen activator (tPA), urat, von Willebrand factor (vWF), vascular endothelial cell adhesion molecule (VCAM), intercellular adhesion molecule (ICAM), TNFalpha, proBNP, E-selectin and asymmetric dimethylarginine)
Measured: The trial visit of week 26
Prothrombotic state
Prothrombotic state (fibrinogen, activated partial thromboplastin time (APTT) and thromboelastography (TEG))
Measured: The trial visit of week 26
Lipid profile
Lipid profile
Measured: The trial visit of week 26
Plasma liraglutide
Plasma liraglutide
Measured: The trial visit of week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Inability to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo Feldt-Rasmussen
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, University of Copenhagen
- Responsible party
- Sponsor-investigator, Bo Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo Feldt-Rasmussen, Prof,MD,DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284230
- Sponsor's protocol ID
- U1111-1149-7801
- Acronym
- LiRA2
- Status last verified
- Aug 2015
- First submitted
- 3 Nov 2014
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycaemic and Cardiovascular Efficacy of Liraglutide in Prediabetic Patients With End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT02284230
- Acronym / sponsor ID
- LiRA2 / U1111-1149-7801
- Conditions
- Kidney Failure, Chronic, Prediabetic State
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bo Feldt-RasmussenUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, University of Copenhagen
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Nov 2014 (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.
The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD). The primary objective is to determine the efficacy of the treatment on glucose tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives include various clinical and biochemical cardiovascular and safety parameters.
We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate other cardiovascular risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide treatment | Active comparator | Drug: LiraglutideSubcutaneous, once daily injection of liraglutide, individually dosed up to 1.8 mg/day. |
| Placebo treatment | Placebo comparator | Drug: PlaceboSubcutaneous, once daily injection of placebo, individually dosed up to 1.8 mg/day. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- End-stage renal disease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis)
- Impaired glucose tolerance (2h plasma glucose ≥ 7,8 and < 11.1 mmol/l following a 75g-OGTT) and/or impaired fasting glucose (fasting plasma glucose ≥ 6.1 and < 7.0 mmol/l) evaluated at the screening visit
Key exclusion criteria (16 listed)
- Diabetes mellitus type 1 or type 2 (diagnose according to WHO criteria)
- Chronic pancreatitis / previous acute pancreatitis
- Known or suspected hypersensitivity to trial product(s) or related products
- Treatment with oral glucocorticoids, calcineurin inhibitors or incretin-based therapy which in the Investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
- Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, which in the investigator's opinion could interfere with the results of the trial
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 treatment |
| Placebo | Drug | Placebo treatment |
Primary outcome
Plasma glucose during oral glucose tolerance test at week 26
Time frame: The trial visit of week 26
Difference between the two treatment arms in plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26
16 secondary outcomes
Hypoglycemic incidents
Time frame: From the randomisation to trial visit of week 26
Fasting values of glucometabolic hormones
Time frame: The trial visit of week 26
Insulin resistance
Time frame: The trial visit of week 26
Beta cell function
Time frame: The trial visit of week 26
Change in glycemic state
Time frame: The trial visit of week 26
Blood pressure
Time frame: The trial visit of week 26
Pulse
Time frame: The trial visit of week 26
Weight
Time frame: The trial visit of week 26
Body composition
Time frame: The trial visit of week 26
Cardiac function and perfusion
Time frame: The trial visit of week 26
Cardiac autonomic function
Time frame: The trial visit of week 26
Arterial stiffness
Time frame: The trial visit of week 26
Cardiovascular and endothelial risk markers
Time frame: The trial visit of week 26
Prothrombotic state
Time frame: The trial visit of week 26
Lipid profile
Time frame: The trial visit of week 26
Plasma liraglutide
Time frame: The trial visit of week 26
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
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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.
Bo Feldt-Rasmussen, Prof,MD,DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liraglutide in people with Kidney Failure, Chronic and Prediabetic State, run by Bo Feldt-Rasmussen 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 2 inclusion and 16 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: withdrawn, as of the sponsor's last update on 24 Aug 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Plasma glucose during oral glucose tolerance test at week 26 (time frame: The trial visit of week 26). 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 24 Aug 2015.