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Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes
AIM: To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add‐on to sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor therapy. MATERIALS AND METHODS: In this 26‐week, phase IIIb, open‐label, parallel‐group, treat‐to‐ta...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593861/ https://www.ncbi.nlm.nih.gov/pubmed/30761720 http://dx.doi.org/10.1111/dom.13666 |
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author | Philis‐Tsimikas, Athena Billings, Liana K. Busch, Robert Portillo, Cristobal Morales Sahay, Rakesh Halladin, Natalie Eggert, Sarah Begtrup, Kamilla Harris, Stewart |
author_facet | Philis‐Tsimikas, Athena Billings, Liana K. Busch, Robert Portillo, Cristobal Morales Sahay, Rakesh Halladin, Natalie Eggert, Sarah Begtrup, Kamilla Harris, Stewart |
author_sort | Philis‐Tsimikas, Athena |
collection | PubMed |
description | AIM: To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add‐on to sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor therapy. MATERIALS AND METHODS: In this 26‐week, phase IIIb, open‐label, parallel‐group, treat‐to‐target trial, conducted at 74 sites in 11 countries, insulin‐naïve people aged ≥18 years with glycated haemoglobin (HbA1c) 53–97 mmol/mol (7.0–11.0%), body mass index 20–40 kg/m(2) and inadequately controlled type 2 diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs were randomized 1:1 to once‐daily IDegLira or IGlar U100, both as add‐on to existing therapy. The primary endpoint was change in HbA1c from baseline to week 26. RESULTS: A total of 210 participants were randomized to each treatment arm. Mean HbA1c reductions were 21 mmol/mol (1.9%‐points) with IDegLira and 18 mmol/mol (1.7%‐points) with IGlar U100; confirming non‐inferiority (P < 0.0001) and superiority of IDegLira (difference in HbA1c change –3.90 mmol/mol; 95% confidence interval [CI] –5.45; –2.35 (−0.36%‐points; 95% CI –0.50, –0.21)). Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference −1.92 kg; 95% CI –2.64, –1.19); severe or blood‐glucose‐confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference −15.37 U; 95% CI –19.60, −11.13). The overall treatment‐emergent adverse event rate was higher with IDegLira as a result of higher increased lipase and nausea rates. CONCLUSIONS: The favourable safety and efficacy profile of IDegLira in people with uncontrolled T2D on SGLT2 inhibitors, and lower weight gain and hypoglycaemia risk versus IGlar U100, suggest that clinicians should consider IDegLira initiation in this population. |
format | Online Article Text |
id | pubmed-6593861 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-65938612019-07-10 Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes Philis‐Tsimikas, Athena Billings, Liana K. Busch, Robert Portillo, Cristobal Morales Sahay, Rakesh Halladin, Natalie Eggert, Sarah Begtrup, Kamilla Harris, Stewart Diabetes Obes Metab Original Articles AIM: To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add‐on to sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor therapy. MATERIALS AND METHODS: In this 26‐week, phase IIIb, open‐label, parallel‐group, treat‐to‐target trial, conducted at 74 sites in 11 countries, insulin‐naïve people aged ≥18 years with glycated haemoglobin (HbA1c) 53–97 mmol/mol (7.0–11.0%), body mass index 20–40 kg/m(2) and inadequately controlled type 2 diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs were randomized 1:1 to once‐daily IDegLira or IGlar U100, both as add‐on to existing therapy. The primary endpoint was change in HbA1c from baseline to week 26. RESULTS: A total of 210 participants were randomized to each treatment arm. Mean HbA1c reductions were 21 mmol/mol (1.9%‐points) with IDegLira and 18 mmol/mol (1.7%‐points) with IGlar U100; confirming non‐inferiority (P < 0.0001) and superiority of IDegLira (difference in HbA1c change –3.90 mmol/mol; 95% confidence interval [CI] –5.45; –2.35 (−0.36%‐points; 95% CI –0.50, –0.21)). Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference −1.92 kg; 95% CI –2.64, –1.19); severe or blood‐glucose‐confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference −15.37 U; 95% CI –19.60, −11.13). The overall treatment‐emergent adverse event rate was higher with IDegLira as a result of higher increased lipase and nausea rates. CONCLUSIONS: The favourable safety and efficacy profile of IDegLira in people with uncontrolled T2D on SGLT2 inhibitors, and lower weight gain and hypoglycaemia risk versus IGlar U100, suggest that clinicians should consider IDegLira initiation in this population. Blackwell Publishing Ltd 2019-04-04 2019-06 /pmc/articles/PMC6593861/ /pubmed/30761720 http://dx.doi.org/10.1111/dom.13666 Text en © 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Philis‐Tsimikas, Athena Billings, Liana K. Busch, Robert Portillo, Cristobal Morales Sahay, Rakesh Halladin, Natalie Eggert, Sarah Begtrup, Kamilla Harris, Stewart Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes |
title | Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes |
title_full | Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes |
title_fullStr | Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes |
title_full_unstemmed | Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes |
title_short | Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes |
title_sort | superior efficacy of insulin degludec/liraglutide versus insulin glargine u100 as add‐on to sodium‐glucose co‐transporter‐2 inhibitor therapy: a randomized clinical trial in people with uncontrolled type 2 diabetes |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593861/ https://www.ncbi.nlm.nih.gov/pubmed/30761720 http://dx.doi.org/10.1111/dom.13666 |
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