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Trial · Interventional

CompletedPhase 4Registry data

Effect of LIXIsenatide on the Renal System

Short name ELIXIRS

Overview

Status
Completed
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
Amsterdam UMC, location VUmc · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Netherlands

Start
Sept 2014
Primary completion
Apr 2016
Completion
Apr 2016
First posted
28 Oct 2014 (estimated)
Last update posted
29 Apr 2016 (estimated)
Conditions
Diabetic Kidney Disease · Diabetic Nephropathy · Diabetes Mellitus · Glucagon-Like Peptide 1

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 4

    ELIXIRS

    NCT02276196

    Sept 2014 to Apr 2016

Registry summary

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

Based on preclinical and small-sized studies in non-diabetic individuals, incretin-based therapies, i.e. glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase-4 inhibitors, may hold promise in preventing the onset and progression of diabetic kidney disease. However, the potential renoprotective effects of these agents, that are believed to be effectuated "beyond glucose control", have not been sufficiently detailed in human diabetes. Therefore, the present study aims to explore the mechanistic and clinical effects of GLP-1 receptor agonists on renal physiology and biomarkers in patients with type 2 diabetes. Forty patients with insulin-treated type 2 diabetes will undergo an eight week intervention with lixisenatide or insulin glulisine in order to assess changes in the outcome parameters.

Interventions

  • LixisenatideDrug
  • Insulin glulisineDrug

Arms2

  • Experimental

    Lixisenatide

    Lixisenatide will be administered subcutaneously, once daily for 8 weeks

  • Active comparator

    Insulin glulisine

    Insulin glulisine will be administered subcutaneously, once daily for 8 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Changes from baseline following 8-week treatment with a glucagon-like peptide(GLP)-1 receptor agonist versus insulin glulisine on renal hemodynamics, measured as glomerular filtration rate (GFR) / effective renal plasma flow (ERPF)

    Time frame · 8 weeks

    Registry description

    ml/min

Secondary outcomes(3)
  1. Renal damage, measured by urine biomarkers

    Time frame · 8 weeks

    Registry description

    enzyme immuno assay

  2. Renal tubular function

    Time frame · 8 weeks

    Registry description

    e.g. percentage (%)

  3. Blood Pressure

    Time frame · 8 weeks

    Registry description

    mmHg

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

13 results

Postprandial renal haemodynamic effect of lixisenatide vs once-daily insulin-glulisine in patients with type 2 diabetes on insulin-glargine: An 8-week, randomised, open-label trial.

Tonneijck et al. 2017Diabetes, obesity & metabolismcited by 55

PMID 28449402DOI 10.1111/dom.12985PUB-28449402

Rights unknown13 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 35 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients with type 2 diabetes (HbA1c: 6.5-10.0% or 48-86 mmol/mol) * Stable treatment with basal insulin glargine (dose ±20%) and metformin or basal insulin glargine (dose ±20%) alone for at least 3 months * Fasting plasma glucose \<10 mmol/L or the use of \>50 units of basal insulin glargine * Females must be post-menopausal * Caucasian * Age: 35 - 75 years * Body Mass Index: \>25 kg/m2 * Hypertension should be under control, i.e. \<140/90 mmHg, and treated with an angiotensin-converting enzyme inhibitor or angiotensin-II-receptor blocker for at least 3 months. * Albuminuria should be treated with an angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin-II-receptor blocker (ARB) for at least 3 months. Exclusion Criteria: * Current/chronic use of the following medication: thiazolidinediones, sulfonylurea derivatives, GLP-1 receptor agonists, dipeptidyl peptidase (DPP)-4 inhibitors, glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants and monoamine oxidase inhibitors. Subjects on diuretics, will only be excluded when these drugs cannot be stopped for the duration of the study. * Chronic use of non-steroidal anti-inflammatory drugs will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing * Hypoglycemia unawareness based on investigator judgment * History of severe hypoglycemia that required emergency hospital treatment within 3 months prior to screening * Estimated GFR \<60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation) * Pregnancy * Current urinary tract infection and active nephritis * Recent (\<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke or transient ischemic neurologic disorder * Complaints compatible with or established gastroparesis, neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan) * Active liver disease or a 3-fold elevation of liver enzymes (aspartate aminotransferase/alanine aminotransferase) at screening * History of or actual pancreatic disease * History of or actual malignancy (except basal cell carcinoma) * History of or actual severe mental disease * Substance abuse (alcohol: defined as \>4 units/day) * Allergy to any of the agents used in the study * Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study * Inability to understand the study protocol or give informed consent

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