Title: | 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) |
Author(s): | Wit, H.M. de; Vervoort, G.M. ; Jansen, H.J. ; Grauw, W.J.C. de ; Galan, B.E. de ; Tack, C.J. |
Publication year: | 2014 |
Source: | Diabetologia, vol. 57, iss. 9, (2014), pp. 1812-1819 |
ISSN: | 0012-186X |
DOI: | https://doi.org/10.1007/s00125-014-3302-0 |
Publication type: | Article / Letter to editor |
Please use this identifier to cite or link to this item : https://hdl.handle.net/2066/138546 ![]() |
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Subject: | Radboudumc 0: Other Research RIHS: Radboud Institute for Health Sciences Radboudumc 16: Vascular damage RIHS: Radboud Institute for Health Sciences Radboudumc 6: Metabolic Disorders RIMLS: Radboud Institute for Molecular Life Sciences |
Organization: | Internal Medicine Nephrology Primary and Community Care |
Journal title: |
Diabetologia
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Volume: | vol. 57 |
Issue: | iss. 9 |
Page start: | p. 1812 |
Page end: | p. 1819 |
Abstract: |
AIMS/HYPOTHESIS: The best treatment strategy for a patient with type 2 diabetes who shows pronounced weight gain after the introduction of insulin treatment is unclear. We determined whether addition of a glucagon-like peptide-1 (GLP-1) analogue could reverse pronounced insulin-associated weight gain while maintaining glycaemic control, and compared this with the most practised strategy, continuation and intensification of standard insulin therapy. METHODS: In a 26-week, randomised controlled trial (ELEGANT), conducted in the outpatient departments of one academic and one large non-academic teaching hospital in the Netherlands, adult patients with type 2 diabetes with >/= 4% weight gain during short-term (</= 16 months) insulin therapy received either open-label addition of liraglutide 1.8 mg/day (n = 26) or continued standard therapy (n = 24). A computer-generated random number list was used to allocate treatments. Participants were evaluated every 4-6 weeks for weight, glycaemic control and adverse events. The primary endpoint was between-group weight difference after 26 weeks of treatment (intention to treat). RESULTS: Of 50 randomised patients (mean age 58 years, BMI 33 kg/m(2), HbA1c 7.4% [57 mmol/mol]), 47 (94%) completed the study; all patients were analysed. Body weight decreased by 4.5 kg with liraglutide and increased by 0.9 kg with standard therapy (mean difference -5.2 kg [95% CI -6.7, -3.6 kg]; p < 0.001). The respective changes in HbA1c were -0.77% (-8.4 mmol/mol) and +0.01% (+0.1 mmol/mol) (difference -0.74% [-8.1 mmol/mol]) ([95% CI -1.08%, -0.41%] [-11.8, -4.5 mmol/mol]; p < 0.001); respective changes in insulin dose were -29 U/day and +5 U/day (difference -33 U/day [95% CI -41, -25 U/day]; p < 0.001). In five patients (19%), insulin could be completely discontinued. Liraglutide was well tolerated; no severe adverse events or severe hypoglycaemia occurred. CONCLUSIONS/INTERPRETATION: In patients with pronounced insulin-associated weight gain, addition of liraglutide to their treatment regimen reverses weight, decreases insulin dose and improves glycaemic control, and hence seems a valuable therapeutic option compared with continuation of standard insulin treatment. Trial registration ClinicalTrials.gov NCT01392898. Funding The study was funded by Novo Nordisk.
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