Affiliation:
1. Joslin Diabetes Center Boston Massachusetts USA
2. Harvard Medical School Boston Massachusetts USA
3. Beth Israel Deaconess Medical Center Boston Massachusetts USA
4. Klinikum Schwabing and Klinikum Bogenhausen Munich Germany
5. Tameside and Glossop Integrated Care NHS Foundation Trust Ashton under Lyne and University of Manchester/Manchester Metropolitan University Manchester UK
6. Sanofi Bridgewater New Jersey USA
7. Ividata Life Sciences Levallois‐Perret France
8. Velocity Clinical Research at Medical City Dallas Texas USA
Abstract
AbstractAimTo assess the efficacy and safety of iGlarLixi in older people (≥65 years) with type 2 diabetes (T2D) advancing or switching from oral agents, a glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), or basal insulin.Materials and MethodsThe data of participants aged <65 years and ≥65 years from four LixiLan trials (LixiLan‐O, LixiLan‐G, LixiLan‐L, SoliMix) were evaluated over 26 or 30 weeks.ResultsParticipants aged <65/≥65 years (n = 1039/n = 497) had a mean baseline body mass index of 31.4 and 30.7 kg/m2 and glycated haemoglobin (HbA1c) concentration of 66 mmol/mol (8.2%) and 65 mmol/mol (8.1%), respectively. Least squares mean HbA1c change from baseline to end of treatment (EOT) was −14.32 mmol/mol (−1.31%) (95% confidence interval [CI] −14.97, −13.77 [−1.37%, −1.26%]) for those aged <65 years and −13.66 mmol/mol (−1.25%) (95% CI −14.54, −12.79 [−1.33%, −1.17%]) for those aged ≥65 years. At EOT, achievement of HbA1c targets was similar between the group aged <65 years and the group aged ≥65 years: <53 mmol/mol (<7%) (59.0% and 56.5%, respectively), <59 mmol/mol (<7.5%) (75.5% and 73.0%, respectively) and <64 mmol/mol (<8%) (83.8% and 84.1%, respectively). The incidence and event rate of American Diabetes Association Level 1 hypoglycaemia during the studies were also comparable between the two groups: 26.7% and 28.2% and 1.7 and 2.1 events per patient‐year for the group aged <65 years and the group aged ≥65 years, respectively. A clinically relevant reduction in HbA1c (>1% from baseline for HbA1c ≥64 mmol/mol [≥8%] or ≥0.5% from baseline for HbA1c <64 mmol/mol [<8%]) without hypoglycaemia was attained by 50.0% and 47.6% of participants aged <65 years and ≥65 years, respectively. Adverse events were similar between the two age groups.ConclusionsiGlarLixi is a simple, well‐tolerated, once‐daily alternative for treatment advancement in older people with T2D that provides significant improvements in glycaemic control without increasing hypoglycaemia risk, thus reducing the treatment burden.
Subject
Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine