Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial

Aug 17, 2016Diabetes care

Benefits of a combined adjustable dose of insulin and lixisenatide compared to each drug alone in type 2 diabetes not controlled by pills

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Abstract

Participants using iGlarLixi achieved a mean final HbA1c level of 6.5% after 30 weeks.

iGlarLixi resulted in a greater reduction in HbA1c from baseline (8.1%) compared to iGlar (-1.6%) and Lixi (-0.9%), with statistical significance (P < 0.0001).
74% of participants using iGlarLixi reached the target HbA1c level of less than 7%, compared to 59% with iGlar and 33% with Lixi (P < 0.0001 for all).
Mean body weight decreased slightly with iGlarLixi (-0.3 kg) and Lixi (-2.3 kg), while it increased with iGlar (+1.1 kg).
The incidence of documented symptomatic hypoglycemia was similar between iGlarLixi and iGlar, but lower with Lixi.
iGlarLixi improved postprandial glycemic control compared to iGlar and had lower rates of nausea (9.6%) and vomiting (3.2%) than Lixi (24% and 6.4%, respectively).

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OBJECTIVE: To evaluate efficacy and safety of LixiLan (iGlarLixi), a novel titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi), compared with both components, iGlar and Lixi, given separately in type 2 diabetes inadequately controlled on metformin with or without a second oral glucose-lowering drug.

RESEARCH DESIGN AND METHODS: After a 4-week run-in to optimize metformin and stop other oral antidiabetic drugs, participants (N = 1,170, mean diabetes duration ∼8.8 years, BMI ∼31.7 kg/m) were randomly assigned to open-label once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum insulin dose of 60 units/day, or to once-daily Lixi (20 μg/day) while continuing with metformin. The primary outcome was HbAchange at 30 weeks. 2 1c

RESULTS: Greater reductions in HbAfrom baseline (8.1% [65 mmol/mol]) were achieved with iGlarLixi compared with iGlar and Lixi (-1.6%, -1.3%, -0.9%, respectively), reaching mean final HbAlevels of 6.5% (48 mmol/mol) for iGlarLixi versus 6.8% (51 mmol/mol) and 7.3% (56 mmol/mol) for iGlar and Lixi, respectively (both P < 0.0001). More subjects reached target HbA<7% with iGlarLixi (74%) versus iGlar (59%) or Lixi (33%) (P < 0.0001 for all). Mean body weight decreased with iGlarLixi (-0.3 kg) and Lixi (-2.3 kg) and increased with iGlar (+1.1 kg, difference 1.4 kg, P < 0.0001). Documented symptomatic hypoglycemia (≤70 mg/dL) was similar with iGlarLixi and iGlar (1.4 and 1.2 events/patient-year) and lower with Lixi (0.3 events/patient-year). iGlarLixi improved postprandial glycemic control versus iGlar and demonstrated considerably fewer nausea (9.6%) and vomiting (3.2%) events than Lixi (24% and 6.4%, respectively). 1c1c1c

CONCLUSIONS: iGlarLixi complemented iGlar and Lixi effects to achieve meaningful HbAreductions, close to near normoglycemia without increases in either hypoglycemia or weight, compared with iGlar, and had low gastrointestinal adverse effects compared with Lixi. 1c

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Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial

Abstract

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