• Open Access

One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial

Authors


  • Disclosures RP has attended advisory panels for GlaxoSmithKline; has received research grants/participated in clinical trials for Merck & Co., Novartis Pharmaceuticals, Novo Nordisk Inc., Roche, Takeda Global Research Development Center Inc., Eli Lilly & Co., Merck & Co., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Pfizer Inc., sanofi-aventis; has acted as consultant for GlaxoSmithKline; has received honoraria from Novartis Pharmaceuticals Corp, Novo Nordisk Inc., Roche and Takeda Global Research Development Center and has attended speakers’ bureaux for Merck & Co. MN has received research grants from Bayer Vital Pharma, Eli Lilly & Co., Menarini/Berlin-Chemie, Merck Sharp & Dohme, Novartis Pharma and Novo Nordisk A/S; has accepted honoraria for membership in advisory boards and consulting, and has received honoraria for speaking on incretin-based antidiabetic medications from Amylin Pharmaceuticals, AstraZeneca, Bayer Vital Pharma, Berlin-Chemie/Menarini, Biovitrum, Boehringer Ingelheim, Eli Lilly & Co., GlaxoSmithKline, Hoffman La Roche, Novartis Pharma, Novo Nordisk A/S, sanofi-aventis Pharma and Takeda. TB has attended advisory panels for Amylin Pharmaceuticals; has received research support from Animas Corporation, Becton Dickinson, CPEX Pharmaceuticals, Dexcom, Eli Lilly & Co., GlaxoSmithKline, Medtronic MiniMed, Merck, Novo Nordisk Inc., Resmed and sanofi-aventis; and has attended speakers’ bureaux for Amylin Pharmaceuticals Inc., Dexcom, Eli Lilly & Co., Medtronic MiniMed, Novo Nordisk Inc., Roche Diagnostics and sanofi-aventis. EM has attended advisory panels for Merck Sharp & Dohme, Novartis, Novo Nordisk and sanofi-aventis.
    RC has attended advisory boards for Novo Nordisk, Bayer, Roche, CeQur, Eli Lilly and Abbott; has received support for educational activities from Lifescan, Eli Lilly, Merck, Novartis and sanofi-aventis; has or is principal or co-investigator for sponsored clinical trials research for Amylin, Abbott, Bayer, Daiichi Sankyo, Dexcom, Edwards Lifesciences, Eli Lilly, Hygeia, Intarcia, Johnson & Johnson/Lifescan, Mannkind, Medtronic, Merck, Novo Nordisk, Quotient Diagnostics, ResMed, Roche, sanofi-aventis, Takeda and Valeritas; and is an employee of the International Diabetes Center at Park Nicollet. All honoraria, speaking fees, consulting fees and research and educational support are paid directly to the non-profit International Diabetes Center of which RP is a salaried employee; he receives no personal payments for any of these activities. SF has acted as consultant and attended speakers’ bureaux for Novo Nordisk A/S. AG is an advisor and speaker for Novo Nordisk, Merck, GlaxoSmithKline and Sankyo. ABT is an employee of Novo Nordisk and was directly involved in study conduct. HH is an employee of Novo Nordisk and was directly involved in study conduct. MD has attended advisory panels for Eli Lilly & Co., Merck Sharp & Dohme Ltd., Novartis Pharmaceuticals, Novo Nordisk Pharma Ltd., Schering-Plough, Roche and Bristol-Myers Squibb; has received research support from Eli Lilly & Co., Merck Sharp & Dohme Ltd., Novartis Pharmaceuticals, Novo Nordisk Pharma UK and GlaxoSmithKline; and has received honoraria for lectures from Eli Lilly & Co., Merck Sharp & Dohme Ltd., Novartis Pharmaceuticals and Novo Nordisk Pharma Ltd.

  • Clinical trial registration number: clinicaltrials.gov, NCT00700817

  • Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://wileyonlinelibrary.com/onlineopen#OnlineOpen_Terms

Dr Richard Pratley, Diabetes and Metabolism Translational Medicine Unit, Colchester Research Facility 110C, University of Vermont College of Medicine, Burlington, VT 04556, USA
Tel.: + 1 802 656 5811
Fax: + 1 802 656 8031
Email: richard.pratley@uvm.edu

Summary

Aim:  The aim of this study was to compare the efficacy and safety of once-daily human glucagon-like peptide-1 analogue liraglutide with dipeptidyl peptidase-4 inhibitor sitagliptin, each added to metformin, over 52 weeks in individuals with type 2 diabetes.

Methods:  In an open-label, parallel-group trial, metformin-treated participants were randomised to liraglutide 1.2 mg/day (= 225), liraglutide 1.8 mg/day (= 221) or sitagliptin 100 mg/day (= 219) for 26 weeks (main phase). Participants continued the same treatment in a 26-week extension.

Results:  Liraglutide (1.2 or 1.8 mg) was superior to sitagliptin for reducing HbA1c from baseline (8.4–8.5%) to 52 weeks: −1.29% and −1.51% vs. −0.88% respectively. Estimated mean treatment differences between liraglutide and sitagliptin were as follows: −0.40% (95% confidence interval −0.59 to −0.22) for 1.2 mg and −0.63% (−0.81 to −0.44) for 1.8 mg (both p < 0.0001). Weight loss was greater with liraglutide 1.2 mg (−2.78 kg) and 1.8 mg (−3.68 kg) than sitagliptin (−1.16 kg) (both p < 0.0001). Diabetes Treatment Satisfaction Questionnaire scores increased significantly more with liraglutide 1.8 mg than with sitagliptin (p = 0.03). Proportions of participants reporting adverse events were generally comparable; minor hypoglycaemia was 8.1%, 8.3% and 6.4% for liraglutide 1.2 mg, 1.8 mg and sitagliptin respectively. Gastrointestinal side effects, mainly nausea, initially occurred more frequently with liraglutide, but declined after several weeks.

Conclusion:  Liraglutide provides greater sustained glycaemic control and body weight reduction over 52 weeks. Treatment satisfaction was significantly greater with 1.8 mg liraglutide, similar to 26-week results. The safety profiles of liraglutide and sitagliptin are consistent with previous reports.

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