Liraglutide reverses insulin-associated weight gain, improves glycemic control and decreases insulin dose in patients with type 2 diabetes. Results from a 26-week, randomized, controlled trial (ELEGANT)
Wit, H.M. de, Vervoort, G.M.M., Jansen, H.J.J., Grauw, W.J.C. de, Galan, B.E. de, Tack, C.J.
Voorzitter(s): dr. B.J. Looij, Geleen & dr. Y.W.J. Sijpkens, Den Haag
Locatie(s): Zaal 2.1
Categorie(ën):
Introduction: Weight gain, which is often encountered within the first 9-12 months after introducing insulin therapy in patients with type 2 diabetes, is obviously undesirable and may offset the beneficial effects of insulin. Whether addition of a GLP-1 analogue is efficacious in this situation is currently unknown.
Aim of the study: To determine whether the addition of liraglutide to insulin therapy can reverse insulin-associated weight gain while maintaining glycemic control in patients with type 2 diabetes.
Materials and Methods: The ELEGANT trial was conducted in the outpatient departments of 1 academic and 1 large nonacademic teaching hospital in the Netherlands, from February to October 2013. Adult patients with type 2 diabetes on short-term (≤16 months) insulin therapy with >4% associated weight gain were randomized between open-label addition of liraglutide 1,8 mg/day (n=26) and continuation of standard therapy (n=24) during 26 weeks. They were evaluated every 4-6 weeks for weight, glycemic control and adverse events. Primary outcome was between-group weight difference after 26 weeks (intention to treat analysis).
Results: Of 64 eligible patients, 50 (mean age 58 years, BMI 33 kg/m2, HbA1c 7.4%) were randomized: 25 patients (96%) in the liraglutide group and 22 patients (92%) in the standard therapy group completed the study. Body weight decreased 4,5 kg with liraglutide and increased 0,9 kg with standard therapy (mean difference -5.2 kg [95%CI, -6.7 to -3.6 kg]; P <0.001). The respective change in HbA1c was -0.77% and +0.01% (difference -0.74% ([95%CI, -1.08 to -0.41%]; P <0.001); respective changes in insulin dose were -29 U/day and +5 U/day (difference -33 U/day, [95%CI, -41 to -25 U/day]; P <0.001). In 5 patients (19%), insulin could be completely discontinued. Liraglutide was well tolerated, only 1 patient withdrew because of side effects. No severe adverse events or severe hypoglycemia occurred.
Conclusion: In patients with pronounced insulin-associated weight gain, the addition of liraglutide to insulin therapy reverses weight, decreases insulin dose and improves glycemic control, compared to continuation of standard insulin therapy. These findings suggest that adding liraglutide in patients with pronounced insulin-associated weight gain is a reasonable therapeutic option.
- Over Wit, H.M. de
- Over Vervoort, G.M.M.
- Over Jansen, H.J.J.
- Over Grauw, W.J.C. de
- Over Galan, B.E. de
- Over Tack, C.J.