Dataset Information

IGlarLixi: A New Once-Daily Fixed-Ratio Combination of Basal Insulin Glargine and Lixisenatide for the Management of Type 2 Diabetes.

ABSTRACT: Background:Patients with type 2 diabetes require treatment intensification to maintain glycemic control. Clinician reluctance, patient injection fears, hypoglycemia, weight gain, or other objections may lead to clinical inertia, whereby therapy is not intensified and patients live with uncontrolled hyperglycemia and increased risk for complications. Initiation of injectable therapy with a glucagon-like peptide (GLP)-1 receptor agonist and/or basal insulin is a recommended option for patients with type 2 diabetes inadequately controlled on one or more oral agents. Purpose:This article reviews clinical evidence and provides information on dosing and administration of iGlarLixi, a titratable fixed-ratio combination of insulin glargine and the GLP-1 receptor agonist lixisenatide that effectively lowers both fasting and postprandial glucose levels. Findings:In phase 3 trials, iGlarLixi provided greater A1C reduction than insulin glargine or lixisenatide alone, without increased hypoglycemia risk compared with insulin glargine. iGlarLixi did not lead to weight gain versus insulin glargine and was associated with a lower frequency of gastrointestinal adverse effects than lixisenatide. iGlarLixi was recently approved by the U.S. Food and Drug Administration to improve glycemic control in adults with type 2 diabetes inadequately controlled on basal insulin (<60 units daily) or lixisenatide. iGlarLixi is administered by subcutaneous injection once daily, and the dose is titrated based on each patient's insulin needs using a simple titration algorithm. Conclusion:iGlarLixi offers an effective and well-tolerated treatment option for patients with type 2 diabetes requiring additional glycemic control, with comparable or improved safety outcomes than its separate components. Because of its simple regimen and low rate of adverse effects, iGlarLixi may improve adherence and, consequently, therapeutic outcomes.

SUBMITTER: Hinnen D

PROVIDER: S-EPMC5951239 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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iGlarLixi: A New Once-Daily Fixed-Ratio Combination of Basal Insulin Glargine and Lixisenatide for the Management of Type 2 Diabetes.

Hinnen Debbie D Strong Jodi J

Diabetes spectrum : a publication of the American Diabetes Association 20180501 2

<h4>Background</h4>Patients with type 2 diabetes require treatment intensification to maintain glycemic control. Clinician reluctance, patient injection fears, hypoglycemia, weight gain, or other objections may lead to clinical inertia, whereby therapy is not intensified and patients live with uncontrolled hyperglycemia and increased risk for complications. Initiation of injectable therapy with a glucagon-like peptide (GLP)-1 receptor agonist and/or basal insulin is a recommended option for pati ...[more]

PMID: 29773934

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Project description:ObjectivesTo assess the effectiveness and safety of insulin glargine and lixisenatide (iGlarLixi) fixed-ratio combination on a cohort of Romanian adults with type 2 diabetes (T2D).DesignOpen-label, 24-week, prospective cohort study.Setting65 secondary care diabetes centres in Romania.ParticipantsThe study included 901 adults with T2D suboptimally controlled with previous oral antidiabetic drugs (OADs)±basal insulin (BI) who initiated treatment with iGlarLixi upon the decision of the investigator. Major exclusion criteria were iGlarLixi contraindications and refusal to participate. 876 subjects received at least one dose of iGlarLixi (intention-to-treat/safety population).Primary and secondary outcome measuresThe primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 24 in the modified intention-to-treat population (study participants with HbA1c available at baseline and week 24). Secondary efficacy outcomes were percentage of participants reaching HbA1c targets and change in fasting plasma glucose (FPG).ResultsMean baseline HbA1c was 9.2% (SD 1.4) and FPG was 10.8 mmol/L (2.9). Mean HbA1c change was -1.3% (95% CI: -1.4% to -1.2%, p<0.0001) at week 24. HbA1c levels ≤6.5%, <7% and<7.5% at week 24 were achieved by 72 (8.9%), 183 (22.6%) and 342 (42.3%) participants, respectively. Mean FPG change was -3.1 mmol/L (95% CI: -3.3 to -2.8, p<0.001) at week 24. Mean body weight change was -1.6 kg (95% CI: -1.9 to -1.3, p<0.001) at 24 weeks. Mean iGlarLixi dose increased from 19.5 U (SD 7.7) and 30.1 U (10.0) to 30.2 U (8.9) (ratio 2/1 pen) and 45.0 U (11.6) (ratio 3/1 pen). Adverse events (AEs) were reported by 43 (4.9%) participants (18 (2.1%) gastrointestinal) with 4 (0.5%) reporting serious AEs. 13 (1.5%) participants reported at least one event of symptomatic hypoglycaemia, with one episode of severe hypoglycaemia reported.ConclusionsIn a real-world setting, 24-week treatment with iGlarLixi provided a significant reduction of HbA1c with body weight loss and low hypoglycaemia risk in T2D suboptimally controlled with OADs±BI treatment.

Dataset Information

IGlarLixi: A New Once-Daily Fixed-Ratio Combination of Basal Insulin Glargine and Lixisenatide for the Management of Type 2 Diabetes.

Publications

iGlarLixi: A New Once-Daily Fixed-Ratio Combination of Basal Insulin Glargine and Lixisenatide for the Management of Type 2 Diabetes.

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