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Type 2 Diabetes MellitusPhase 4NCT01394341

Liraglutide Treatment to Patients With Severe Renal Insufficiency

A Phase 4 study testing Liraglutide in people with Type 2 Diabetes Mellitus and End-stage Renal Disease, run by Bo Feldt-Rasmussen at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is new and fundamentally different from the classical treatments with oral antidiabetic agents and insulin. Read more about this study

Who is it for?
Ages 18 to 85 years
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
40 participants
Where
3 sitesDenmark
Study dates
Sep 2011to Oct 2013
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female; aged 18-85 years
  • End-stage renal disease
  • Chronic dialysis treatment (minimum 3 months)
  • T2D (diagnosed according to WHO criteria)
  • Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin
  • Documented beta cell function (evaluated by a glucagon test)
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  • Inclusion criteria - patients with T2D and normal kidney function
  • Male or female; aged 18-85 years
  • Normal kidney function: Plasma creatinine <0.105 mmol/L for men and <0.090 mmol/L for women
  • T2D (diagnosed according to WHO criteria)
  • Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin
  • Documented beta cell function (evaluated by a glucagon test)
  • Hemoglobin A1c ≥6.5%

Who cannot join

  • Type 1 diabetes mellitus
  • Chronic pancreatitis / previous acute pancreatitis
  • Known or suspected hypersensitivity to trial product(s) or related products
  • Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors or other drugs, 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 investigators' opinion could interfere with the results of the trial
  • Inflammatory bowel disease
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  • 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 ≤ 18.5 kg/m2 or ≥ 50.0 kg/m2
  • Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
  • Clinical signs of diabetic gastroparesis
  • Impaired liver function (transaminases >two times upper reference levels)
  • 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

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Department of Endocrinology PE, Copenhagen University Hospital, Rigshospitalet

    Copenhagen Ø, Copenhagen, 2100

  • Department of Nephrology P, Copenhagen University Hospital, Rigshospitalet

    Copenhagen Ø, Copenhagen, 2100

  • Department of Internal Medicine H, Hillerød Hospital

    Hillerød, 3400

Other trials in Denmark

About this study

Official title: Safety and Effect of Liraglutide in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is new and fundamentally different from the classical treatments with oral antidiabetic agents and insulin. The novel and original aspect of this investigator-initiated study is the focus on treatment with an incretin-based agent (the GLP-1 analogue liraglutide) in T2D patients with severely reduced kidney function. At present there is virtually no knowledge of the physiology and clinical implications of the role of incretin hormones and incretin-based therapy in this group of diabetic patients.The aim of the study is to establish an evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of antidiabetic drugs for patients with type T2D and severe renal insufficiency. The overall hypothesis is that patients with T2D and severe renal insufficiency will tolerate and benefit from treatment with the GLP-1 analogue liraglutide, hereby improving glycaemic control and reducing risk factors of cardiovascular disease

Being tested
Liraglutide
Keywords
Liraglutide, Uremia, Dialysis, Type 2 diabetes mellitus, Safety, Efficacy
Medical subject headings
Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Uremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Victoza

    Daily sc. injection, individual dosage

Study groups in NCT01394341
Study groupRoleWhat they receive
T2D, Dialysis, LiraglutideActive comparatorDaily liraglutide treatment Chronic dialysis treatment
Receives: Drug: Liraglutide
T2D, Dialysis, PlaceboPlacebo comparatorDaily placebo Chronic dialysis treatment
Receives: Drug: Liraglutide
T2D, Normal kidney function, LiraglutideActive comparatorDaily Liraglutide treatment Normal kidney function
Receives: Drug: Liraglutide
T2D, Normal kidney function, PlaceboPlacebo comparatorDaily placebo treatment Normal kidney function
Receives: Drug: Liraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma liraglutide concentration (pmol/L)

    Plasma liraglutide concentration evaluated over time during continuous intervention

    Measured: 12 weeks

Secondary outcomes (4)

  1. Hypoglycaemia; minor or major

    Number of hypoglycaemic episodes during intervention. Minor (blood glucose <3.1 mmol/L, no need for assistance). Major (blood glucose <3.1 mmol/L, assistance from third person required)

    Measured: 12 weeks

  2. Glycaemic control

    Glycaemic control evaluated from 3 daily measurements of blood glucose, from 4 periods of 24-hour tissue glucose measurements (5 days each) and from HbA1c during the intervention period.

    Measured: 12 weeka

  3. Pancreatic beta-cell function

    Pancreatic beta-cell function evaluated from insulin- and C-peptide-secretion during a standard meal test 3 times during the intervention period.

    Measured: 12 weeks

  4. Cardiovascular risk factors (lipids and blood pressure)

    Blood pressure will be evaluated at each visit and lipid profile (HDL, LDL, total cholesterol and triglyceride) 3 times during the intervention period.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01394341
Sponsor's protocol ID
H-3-2011-032
Other IDs
2010-021922-36
Status last verified
Oct 2013
First submitted
11 Jul 2011
Last updated
9 Oct 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

  • Idorn T, Knop FK, Jorgensen MB, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and Efficacy of Liraglutide in Patients With Type 2 Diabetes and End-Stage Renal Disease: An Investigator-Initiated, Placebo-Controlled, Double-Blind, Parallel-Group, Randomized Trial. Diabetes Care. 2016 Feb;39(2):206-13. doi: 10.2337/dc15-1025. Epub 2015 Aug 17.

    PubMed 26283739

  • Idorn T, Knop FK, Jorgensen M, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and efficacy of liraglutide in patients with type 2 diabetes and end-stage renal disease: protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded, parallel intervention study. BMJ Open. 2013 Apr 26;3(4):e002764. doi: 10.1136/bmjopen-2013-002764. Print 2013.

    PubMed 23624993

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide in people with Type 2 Diabetes Mellitus and End-stage Renal Disease, run by Bo Feldt-Rasmussen at 3 sites 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 13 inclusion and 15 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 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Plasma liraglutide concentration (pmol/L) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01394341, which also lists 3 linked publications.

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 9 Oct 2013.

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