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Impact of baseline HbA1c, diabetes duration and BMI on clinical outcomes in the LixiLan-O trial testing iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) versus insulin glargine and lixisenatide monocomponents.

Impact of baseline HbA1c, diabetes duration and BMI on clinical outcomes in the LixiLan-O trial testing iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) versus insulin glargine and lixisenatide monocomponents.
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Davies MJ, Leiter LA, Guerci B, Grunberger G, Ampudia-Blasco FJ, Yu C, Stager W, Niemoeller E, Souhami E, Rosenstock J,


Davies MJ, Leiter LA, Guerci B, Grunberger G, Ampudia-Blasco FJ, Yu C, Stager W, Niemoeller E, Souhami E, Rosenstock J, (click to view)

Davies MJ, Leiter LA, Guerci B, Grunberger G, Ampudia-Blasco FJ, Yu C, Stager W, Niemoeller E, Souhami E, Rosenstock J,

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Diabetes, obesity & metabolism 2017 04 22() doi 10.1111/dom.12980
Abstract

To determine whether baseline characteristics impact clinical outcomes in the LixiLan-O trial (N = 1170), the efficacy and safety of iGlarLixi, a titratable fixed-ratio combination of insulin glargine 100 U (iGlar) and lixisenatide (Lixi) was compared with iGlar or Lixi alone in patients with uncontrolled type 2 diabetes mellitus (T2DM) on oral therapy. Subgroups according to baseline glycated haemoglobin (HbA1c; <8%, ≥8% [<64, ≥64 mmol/mol]); T2DM disease duration (<7, ≥7 years) and body mass index (BMI; <30, ≥30 kg/m(2) ) were investigated. In all subpopulations, iGlarLixi was consistently statistically superior to iGlar and Lixi alone in reducing HbA1c from baseline to week 30; higher proportions of patients achieved HbA1c <7% (<53 mmol/mol) with iGlarLixi versus iGlar and Lixi alone. Compared with iGlar, iGlarLixi showed a substantial decrease in 2-hour postprandial plasma glucose, and mitigation of weight gain, with no differences between subpopulations in incidence of symptomatic hypoglycaemia. iGlarLixi consistently improved glycaemic control compared with iGlar and Lixi alone, without weight gain or increase in hypoglycaemic risk compared with iGlar in subpopulations tested, regardless of baseline HbA1c, disease duration and BMI. Clinical trial number: NCT02058147.

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