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Trial · Interventional

CompletedPhase 4Registry data

Liraglutide Treatment to Patients With Severe Renal Insufficiency

NCTNCT01394341 (opens ClinicalTrials.gov in a new tab)Other idH-3-2011-032Other id2010-021922-36
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
Bo Feldt-Rasmussen · Other
Design
Randomized · Double masking
Countries
1 country

Denmark

Start
Sept 2011
Primary completion
Oct 2013
Completion
Oct 2013
First posted
14 Jul 2011 (estimated)
Last update posted
9 Oct 2013 (estimated)
Conditions
Type 2 Diabetes Mellitus · End-stage Renal Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph 4

    Liraglutide Treatment to Patients With Severe Renal Insufficiency

    NCT01394341

    Sept 2011 to Oct 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • LiraglutideDrug

Arms4

  • Active comparator

    T2D, Dialysis, Liraglutide

    Daily liraglutide treatment Chronic dialysis treatment

  • Placebo comparator

    T2D, Dialysis, Placebo

    Daily placebo Chronic dialysis treatment

  • Active comparator

    T2D, Normal kidney function, Liraglutide

    Daily Liraglutide treatment Normal kidney function

  • Placebo comparator

    T2D, Normal kidney function, Placebo

    Daily placebo treatment Normal kidney function

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Plasma liraglutide concentration (pmol/L)

    Time frame · 12 weeks

    Registry description

    Plasma liraglutide concentration evaluated over time during continuous intervention

Secondary outcomes(4)

  1. Hypoglycaemia; minor or major

    Time frame · 12 weeks

    Registry description

    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)

  2. Glycaemic control

    Time frame · 12 weeka

    Registry description

    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.

  3. Pancreatic beta-cell function

    Time frame · 12 weeks

    Registry description

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

  4. Cardiovascular risk factors (lipids and blood pressure)

    Time frame · 12 weeks

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results
Source linkSee results (15)

Indexing hint: Randomized controlled trial · 2016

7 results

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.

Idorn et al. 2016Diabetes carecited by 74

PMID 26283739DOI 10.2337/dc15-1025PUB-26283739

Rights unknown7 results
Source linkSee results (7)

More studies

1 study on this page

PubMed tag: none · 2013

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.

Idorn et al. 2013BMJ opencited by 10

PMID 23624993PMC3641449DOI 10.1136/bmjopen-2013-002764PUB-23624993

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria - patients with T2D in dialysis * 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) 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% Exclusion Criteria - both groups * 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 * 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

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