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Trial · Interventional

Status unknownNot applicableRegistry data

Liraglutide and Insulin Therapy in Patients With Type 2 Diabetes

Short name ELEGANT

NCTNCT01392898 (opens ClinicalTrials.gov in a new tab)Other idLir-HJCJ-03
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
50 participants (actual)
Sponsor
Radboud University Medical Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Netherlands

Start
Feb 2012
Primary completion
May 2014 (estimated)
Completion
May 2014 (estimated)
First posted
13 Jul 2011 (estimated)
Last update posted
2 Aug 2013 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. N/A

    ELEGANT

    NCT01392898

    Feb 2012 to est. May 2014

Registry summary

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

Insulin therapy is frequently needed to achieve adequate glycaemic control in type 2 diabetes. Although insulin is an effective treatment modality, this is often at the expense of significant weight gain. Weight gain is obviously undesirable in an already overweight population, but may also deter further optimization of insulin therapy. Large inter-individual differences exist in the level of weight gain after initiation of insulin therapy, but no clear predictive factors have prospectively been identified thus far. Liraglutide (Victoza®), a human glucagon-like peptide-1 (GLP-1) analogue, improves glycaemic control and reduces weight. We hypothesize that in patients who show (excessive) weight gain after introducing insulin therapy, adding liraglutide is effective in reversing body weight while preserving glycaemic control.

Interventions

  • liraglutideDrug
  • InsulinDrug

Arms2

  • Experimental

    liraglutide

  • Active comparator

    insulin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Body weight change (measured body weight at 26 weeks minus baseline body weight)

    Time frame · 26 weeks (26 weeks - baseline)

    Registry description

    Measuring body weight after 26 weeks minus baseline body weight as the change in body weight after Liraglutide treatment.

Secondary outcomes(1)

  1. Measuring change in insulin dose (insulin dose at 26 weeks minus insulin dose at baseline)

    Time frame · 26 weeks (26 weeks -baseline)

    Registry description

    Change in insulin dose by measuring insulin dose at 26 weeks minus the insulin dose at baseline.

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.

A trial that is still running, or that stopped early, may post results later.

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 · 2014

6 results

Liraglutide reverses pronounced insulin-associated weight gain, improves glycaemic control and decreases insulin dose in patients with type 2 diabetes: a 26 week, randomised clinical trial (ELEGANT).

de Wit et al. 2014Diabetologiacited by 57

PMID 24947583DOI 10.1007/s00125-014-3302-0PUB-24947583

Rights unknown6 results
Source linkSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients with type 2 diabetes mellitus on short-term insulin therapy (≤ 12 months); all types of insulin allowed * Documented insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy until inclusion * Age 18-75 years * BMI ≥ 25 kg/m2 * Stable glycaemic control mirrored by HbA1c ≥ 6.5 and ≤ 8.5 % Exclusion Criteria: * Inability to provide informed consent * Type 1 diabetes mellitus, MODY diabetes, or LADA diabetes (presence of anti-GAD) * Presence of any medical condition that might interfere with the current study protocol. * Inflammatory bowel disease (e.g. M. Crohn, ulcerative colitis) * Recurrent hypoglycaemic events * Diabetic gastroparesis * Heart failure (LVEF ≤ 30%) * Use of TZDs (glitazones), DDP-IV (dipeptidylpeptidase-inhibitor) * Use of medication associated with impaired glucose metabolism including corticosteroids * Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women) * Pre-existing thyroid disease * Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range) * Renal disease (creatinine \> 130 µmol/l or MDRD-GFR \<30 ml/min/1.73m2)

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