Rory J McCrimmon1, Saud Al Sifri2, Rifat Emral3, Viswanathan Mohan4, Leobardo Sauque-Reyna5, Carlos Trescolí6, Nebojsa Lalic7, Agustina Alvarez8, Nacima Demil9, Mathieu Coudert10, Alka Shaunik11, Mireille Bonnemaire12, Julio Rosenstock13. 1. Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, UK. 2. Al Hada Military Hospital, Taif, Saudi Arabia. 3. Department of Endocrinology and Metabolic Diseases, Ankara University Faculty of Medicine, Ankara, Turkey. 4. Dr. Mohan's Diabetes Specialities Centre & Madras Diabetes Research Foundation, IDF Centre of Excellence in Diabetes Care & ICMR Centre for Advanced Research on Diabetes, Chennai, India. 5. Instituto de Diabetes Obesidad y Nutrición S.C., Cuernavaca, Mexico. 6. Hospital Universitario de La Ribera, Alzira, Spain. 7. Faculty of Medicine of the University of Belgrade, Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Belgrade, Serbia. 8. Sanofi, Buenos Aires, Argentina. 9. Diabetes Medical Operation Department, Sanofi, Chilly-Mazarin, France. 10. Biostatistics and Programming Department, Sanofi, Chilly-Mazarin, France. 11. Sanofi US, Bridgewater, New Jersey, USA. 12. Sanofi, Paris, France. 13. Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.
Abstract
AIM: Premix insulin is commonly used in some regions of the world, despite the higher risk of hypoglycaemia and weight gain compared with basal insulin, based on the premise that it offers a simplified insulin regimen. iGlarLixi is a once-daily titratable fixed-ratio formulation that combines basal insulin glargine 100 units/mL (iGlar) and the GLP-1 RA, lixisenatide, which offers a single-injection option for treatment intensification, with improved HbA1c reductions, similar hypoglycaemia risk and more favourable bodyweight profiles over iGlar alone. This randomized controlled study directly compares, for the first time, treatment intensification with iGlarLixi versus premix insulin analogue biphasic insulin aspart 30 (BIAsp 30) in adults with T2D inadequately controlled on basal insulin in combination with one or two oral antihyperglycaemic drugs. MATERIALS AND METHODS: This was an open-label, active-controlled, comparative, parallel-group, multicentre, phase 3b study. In total, 887 adults with T2D uncontrolled on basal insulin were randomized to switch to either iGlarLixi once daily, or BIAsp 30 twice daily, for 26 weeks. RESULTS: Overall, 887 participants were enrolled (mean age 59.8 years, 50.2% female) from 89 centres in 17 countries. At baseline, 65.6% had a duration of T2D of 10 years or longer, and the mean HbA1c at baseline was 8.6%. CONCLUSIONS: The study directly compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with T2D uncontrolled on basal insulin and one or more oral antihyperglycaemic agents. These results provide robust clinical data that may inform clinicians in their therapeutic management of people with T2D uncontrolled on basal insulin requiring additional therapy.
RCT Entities:
AIM: Premix insulin is commonly used in some regions of the world, despite the higher risk of hypoglycaemia and weight gain compared with basal insulin, based on the premise that it offers a simplified insulin regimen. iGlarLixi is a once-daily titratable fixed-ratio formulation that combines basal insulinglargine 100 units/mL (iGlar) and the GLP-1RA, lixisenatide, which offers a single-injection option for treatment intensification, with improved HbA1c reductions, similar hypoglycaemia risk and more favourable bodyweight profiles over iGlar alone. This randomized controlled study directly compares, for the first time, treatment intensification with iGlarLixi versus premix insulin analogue biphasic insulin aspart 30 (BIAsp 30) in adults with T2D inadequately controlled on basal insulin in combination with one or two oral antihyperglycaemic drugs. MATERIALS AND METHODS: This was an open-label, active-controlled, comparative, parallel-group, multicentre, phase 3b study. In total, 887 adults with T2D uncontrolled on basal insulin were randomized to switch to either iGlarLixi once daily, or BIAsp 30 twice daily, for 26 weeks. RESULTS: Overall, 887 participants were enrolled (mean age 59.8 years, 50.2% female) from 89 centres in 17 countries. At baseline, 65.6% had a duration of T2D of 10 years or longer, and the mean HbA1c at baseline was 8.6%. CONCLUSIONS: The study directly compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with T2D uncontrolled on basal insulin and one or more oral antihyperglycaemic agents. These results provide robust clinical data that may inform clinicians in their therapeutic management of people with T2D uncontrolled on basal insulin requiring additional therapy.
Authors: Soree Ryang; Sang Soo Kim; Ji Cheol Bae; Ji Min Han; Su Kyoung Kwon; Young Il Kim; Il Seong Nam-Goong; Eun Sook Kim; Mi-Kyung Kim; Chang Won Lee; Soyeon Yoo; Gwanpyo Koh; Min Jeong Kwon; Jeong Hyun Park; In Joo Kim Journal: Diabetes Obes Metab Date: 2022-06-09 Impact factor: 6.408