Glucagon-like peptide-1 analog liraglutide in combination with sulfonylurea safely improves blood glucose measures vs sulfonylurea monotherapy in Japanese patients with type 2 diabetes: Results of a 52-week, randomized, multicenter trial.

Abstract

Aims/Introduction: Sulfonylurea (SU) agents are the most effective drugs at lowering blood glucose when used alone. However, their effectiveness declines after a certain period. The addition of liraglutide to existing SU therapy might reverse some of the known drawbacks of SU. This multicenter, randomized, 52-week study assessed the long-term efficacy and safety of adding liraglutide at 0.6 or 0.9 mg/day to existing SU therapy in Japanese patients with inadequately controlled type 2 diabetes. In total, 264 patients were enrolled and received treatment. At week 52, HbA1c in the liraglutide 0.6 mg, liraglutide 0.9 mg and placebo groups was reduced from 9.00 to 7.91%, from 8.61 to 7.33%, and from 8.85 to 8.79%, respectively. The mean difference of HbA1c (95% CI) in the liraglutide 0.6 and 0.9 mg groups vs the placebo group was 0.96 (-1.25 to -0.67) and -1.33 (-1.62 to -1.04), respectively. For the liraglutide 0.6 mg, 0.9 mg and placebo groups, the Japanese Diabetes Society target HbA1c of <6.9% was achieved by 15.1, 39.1 and 4.5% of patients, respectively. Mean fasting plasma glucose at week 52 was lower in the liraglutide groups compared with the placebo group, and mean bodyweight remained unchanged in the liraglutide groups. Most subjects in all three treatment groups reported mild adverse events. No major hypoglycemic episode was reported. Once-daily administration of liraglutide in combination with SU for 52 weeks provided favorable metabolic control, a safety profile and did not alter bodyweight. This trial was registered with ClinicalTrial.gov (no. NCT00395746). (J Diabetes Invest,doi: 10.1111/j.2040-1124.2011.00103.x, 2011).