Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial

To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs). In this phase 3, open-labe...

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Veröffentlicht in:Diabetes care 2020-06, Vol.43 (6), p.1249-1257
Hauptverfasser: Watada, Hirotaka, Takami, Akane, Spranger, Robert, Amano, Atsushi, Hashimoto, Yasuhiro, Niemoeller, Elisabeth
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Sprache:eng
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Zusammenfassung:To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs). In this phase 3, open-label, multicenter trial, 321 patients with HbA ≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA at week 26. Change in HbA from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol], < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA
ISSN:0149-5992
1935-5548
DOI:10.2337/dc19-2452