Safety, tolerability and efficacy of lixisenatide in combination with oral antidiabetic treatment in Japanese patients with type 2 diabetes: An open‐label, multicenter study

Abstract

Aim/IntroductionTo assess the overall safety and efficacy of lixisenatide in combination with background oral antidiabetic drug treatment in Japanese patients with type 2 diabetes, as required by Japanese guidelines.Materials and MethodsA phase 3, multicenter, uncontrolled, open‐label, four‐arm, parallel‐group study of Japanese outpatients with type 2 diabetes was carried out; patients received once‐daily lixisenatide in combination with biguanide, thiazolidinedione, alpha‐glucosidase inhibitors or glinide (NCT01940965). The primary end‐point was safety over 52 weeks; secondary end‐points included absolute change from baseline in glycated hemoglobin A1c at weeks 24 and 52.ResultsA total of 294 patients were enrolled (biguanide, thiazolidinedione, alpha‐glucosidase groups: 73 patients each; glinide group: 75 patients). Overall, 90.4% of patients in the biguanide group, 83.6% in the thiazolidinedione group, 83.6% in the alpha‐glucosidase group and 85.3% in the glinide group reported one or more treatment‐emergent adverse event, the most common of which were nasopharingitis, nausea and constipation. Symptomatic hypoglycemia was reported in 5.5, 0, 1.4, and 10.7% of patients in the biguanide, thiazolidinedione, alpha‐glucosidase and glinide groups, respectively. No severe hypoglycemia was observed. Hemoglobin A1c decreased from baseline at weeks 24 and 52, with mean changes ranging from −0.98 to −1.22%, and from −0.80 to −1.08%, respectively, across all groups.ConclusionsLixisenatide treatment administered daily over 52 weeks was well tolerated and effective in improving glycemic control in Japanese patients with type 2 diabetes uncontrolled with existing oral antidiabetic drug therapies. The use of lixisenatide in combination with oral antidiabetic drugs is a valuable treatment option for Japanese patients with type 2 diabetes after failure of oral antidiabetic treatment alone.

Clinical factors associated with the occurrence of nausea and vomiting in type 2 diabetes patients treated with glucagon‐like peptide‐1 receptor agonists

“…The incidence of nausea/vomiting in the present study was consistent with some previous studies of Japanese patients treated with lixisenatide. However, in patients treated with liraglutide, the present study showed a high incidence of nausea/vomiting compared with previous studies in which the occurrence of GI AEs was reported to be 44–60%, of which nausea occurred in 5–14%.…”

Preference for Oral and Injectable GLP-1 RA Therapy Profiles in Japanese Patients with Type 2 Diabetes: A Discrete Choice Experiment

“…Many injectable therapies of the glucagonlike peptide 1 (GLP-1) receptor agonist (RA) class (including semaglutide, dulaglutide, exenatide, liraglutide, and lixisenatide) have also been developed and approved for use in Japan [10][11][12][13][14][15][16][17]. In addition, a new oral formulation of semaglutide has been investigated in Japanese patients with T2D [18,19].…”