Efficacy and safety of insulin glargine/lixisenatide fixed‐ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP‐L randomized clinical trial

Feb 20, 2020Diabetes, obesity & metabolism

Effectiveness and safety of a combined insulin and diabetes drug in Japanese patients with type 2 diabetes not well controlled by insulin and pills

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Abstract

iGlarLixi achieved a -1.27% reduction in HbA1c compared to -0.53% for insulin glargine at week 26.

iGlarLixi was associated with a greater likelihood of reaching target HbA1c levels of less than 7% (51.8% vs 16.0% for iGlar).
Patients using iGlarLixi experienced weight loss, while those on iGlar gained weight (-0.51 kg vs +0.55 kg).
Documented symptomatic hypoglycemia occurred in 18.8% of iGlarLixi patients compared to 16.7% of those on iGlar.
Gastrointestinal-related adverse events were more common in the iGlarLixi group (33.3% vs 8.6% for iGlar), primarily nausea (16.9% vs 0.8%).
Despite some adverse events, iGlarLixi was generally well-tolerated among participants.

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AIMS: To assess efficacy and safety of fixed-ratio (1:1) combination insulin glargine and lixisenatide (iGlarLixi) compared to insulin glargine U100 (iGlar), with metformin, in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin and oral antidiabetic drugs (OADs).

MATERIALS AND METHODS: This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs. Five hundred and twelve patients were randomized after a 12-week run-in, when iGlar was introduced and/or further titrated and OADs other than metformin were stopped. The primary endpoint was change in HbA1c from baseline to week 26.

RESULTS: iGlarLixi (n = 255) demonstrated significantly greater reductions in HbA1c (-1.27%) than iGlar (n = 257, -0.53%) (LS mean difference: -0.74%, P < .0001) at week 26, confirming the superiority of iGlarLixi. Significantly, more iGlarLixi patients reached target HbA1c <7% at week 26 (51.8% vs 16.0% for iGlar). iGlarLixi patients lost weight in contrast to iGlar patients (-0.51 kg vs +0.55 kg). Documented symptomatic hypoglycemia (plasma glucose ≤ 3.9 mmol/L) was observed in 18.8% of iGlarLixi patients vs 16.7% of iGlar patients. iGlarLixi patients had more gastrointestinal-related adverse events than iGlar patients (33.3% vs 8.6%), primarily nausea (16.9% vs 0.8%). However, the treatment was generally well-tolerated.

CONCLUSIONS: A once-daily injection of iGlarLixi with metformin is an effective, well-tolerated, and simple therapeutic intervention providing significant improvement in glycemic control in Japanese patients with T2DM inadequately controlled on basal insulin and up to two OADs. Clinical Trial Number: NCT02752412.

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Efficacy and safety of insulin glargine/lixisenatide fixed‐ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP‐L randomized clinical trial

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