Cargando…
Empagliflozin as add‐on to linagliptin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial
AIMS: This double‐blind, randomized, placebo‐controlled trial (http://clinicaltrials.gov NCT02453555) evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg as add‐on to linagliptin (Lina) 5 mg (fixed‐dose combination, Empa/Lina 10/5 or 25/5) in insufficiently controlled Japanese type...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099460/ https://www.ncbi.nlm.nih.gov/pubmed/29766636 http://dx.doi.org/10.1111/dom.13352 |
_version_ | 1783348670325850112 |
---|---|
author | Kawamori, Ryuzo Haneda, Masakazu Suzaki, Keiko Cheng, Gang Shiki, Kosuke Miyamoto, Yuki Solimando, Fernando Lee, Christopher Lee, Jisoo George, Jyothis |
author_facet | Kawamori, Ryuzo Haneda, Masakazu Suzaki, Keiko Cheng, Gang Shiki, Kosuke Miyamoto, Yuki Solimando, Fernando Lee, Christopher Lee, Jisoo George, Jyothis |
author_sort | Kawamori, Ryuzo |
collection | PubMed |
description | AIMS: This double‐blind, randomized, placebo‐controlled trial (http://clinicaltrials.gov NCT02453555) evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg as add‐on to linagliptin (Lina) 5 mg (fixed‐dose combination, Empa/Lina 10/5 or 25/5) in insufficiently controlled Japanese type 2 diabetes patients. METHODS: The trial (40 sites; May 2015‐March 2017) involved screening 433 adults (≥20 years) who were treatment‐naive or were using one oral antidiabetic drug for ≥12 weeks, which was discontinued at enrolment. Patients with HbA1c 7.5%‐10.0% after ≥16 weeks of using Lina (pre‐enrolment or during a 16‐week, open‐label period) and 2 weeks of using placebo (Plc) for Empa/Lina 10/5, plus Lina, were randomized (2:1) to once‐daily Empa/Lina 10/5 (n = 182) or Plc/Lina 10/5 (n = 93) for 24 weeks. Patients with HbA1c ≥ 7.0% at Week 24 received Empa/Lina up‐titrated to 25/5 (n = 126) or the corresponding placebo (n = 80), per randomization, from Week 28; 172 Empa/Lina and 84 Plc/Lina patients completed 52 weeks. RESULTS: Change from baseline in HbA1c was greater (P < .0001) with Empa/Lina than with Plc/Lina at Week 24 (primary outcome, −0.93% vs 0.21%; adjusted mean difference, −1.14%) and Week 52 (−1.16% vs 0.06%; adjusted mean difference, −1.22%). More patients with HbA1c < 7.0% and greater decreases in fasting plasma glucose, body weight and systolic blood pressure were seen in the Empa/Lina group than in the Plc/Lina group. Empa/Lina was well tolerated. The adverse events that were more frequent with Empa/Lina were known empagliflozin‐associated events (eg, increased urination, increased blood ketones). There were no adjudication‐confirmed diabetic ketoacidosis events or lower limb amputations. CONCLUSIONS: These results support the notion that empagliflozin‐linagliptin in fixed‐dose combination is a therapeutic option for Japanese patients with type 2 diabetes. |
format | Online Article Text |
id | pubmed-6099460 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-60994602018-08-24 Empagliflozin as add‐on to linagliptin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial Kawamori, Ryuzo Haneda, Masakazu Suzaki, Keiko Cheng, Gang Shiki, Kosuke Miyamoto, Yuki Solimando, Fernando Lee, Christopher Lee, Jisoo George, Jyothis Diabetes Obes Metab Original Articles AIMS: This double‐blind, randomized, placebo‐controlled trial (http://clinicaltrials.gov NCT02453555) evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg as add‐on to linagliptin (Lina) 5 mg (fixed‐dose combination, Empa/Lina 10/5 or 25/5) in insufficiently controlled Japanese type 2 diabetes patients. METHODS: The trial (40 sites; May 2015‐March 2017) involved screening 433 adults (≥20 years) who were treatment‐naive or were using one oral antidiabetic drug for ≥12 weeks, which was discontinued at enrolment. Patients with HbA1c 7.5%‐10.0% after ≥16 weeks of using Lina (pre‐enrolment or during a 16‐week, open‐label period) and 2 weeks of using placebo (Plc) for Empa/Lina 10/5, plus Lina, were randomized (2:1) to once‐daily Empa/Lina 10/5 (n = 182) or Plc/Lina 10/5 (n = 93) for 24 weeks. Patients with HbA1c ≥ 7.0% at Week 24 received Empa/Lina up‐titrated to 25/5 (n = 126) or the corresponding placebo (n = 80), per randomization, from Week 28; 172 Empa/Lina and 84 Plc/Lina patients completed 52 weeks. RESULTS: Change from baseline in HbA1c was greater (P < .0001) with Empa/Lina than with Plc/Lina at Week 24 (primary outcome, −0.93% vs 0.21%; adjusted mean difference, −1.14%) and Week 52 (−1.16% vs 0.06%; adjusted mean difference, −1.22%). More patients with HbA1c < 7.0% and greater decreases in fasting plasma glucose, body weight and systolic blood pressure were seen in the Empa/Lina group than in the Plc/Lina group. Empa/Lina was well tolerated. The adverse events that were more frequent with Empa/Lina were known empagliflozin‐associated events (eg, increased urination, increased blood ketones). There were no adjudication‐confirmed diabetic ketoacidosis events or lower limb amputations. CONCLUSIONS: These results support the notion that empagliflozin‐linagliptin in fixed‐dose combination is a therapeutic option for Japanese patients with type 2 diabetes. Blackwell Publishing Ltd 2018-06-01 2018-09 /pmc/articles/PMC6099460/ /pubmed/29766636 http://dx.doi.org/10.1111/dom.13352 Text en © 2018 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 Kawamori, Ryuzo Haneda, Masakazu Suzaki, Keiko Cheng, Gang Shiki, Kosuke Miyamoto, Yuki Solimando, Fernando Lee, Christopher Lee, Jisoo George, Jyothis Empagliflozin as add‐on to linagliptin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial |
title | Empagliflozin as add‐on to linagliptin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial |
title_full | Empagliflozin as add‐on to linagliptin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial |
title_fullStr | Empagliflozin as add‐on to linagliptin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial |
title_full_unstemmed | Empagliflozin as add‐on to linagliptin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial |
title_short | Empagliflozin as add‐on to linagliptin in a fixed‐dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial |
title_sort | empagliflozin as add‐on to linagliptin in a fixed‐dose combination in japanese patients with type 2 diabetes: glycaemic efficacy and safety profile in a 52‐week, randomized, placebo‐controlled trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6099460/ https://www.ncbi.nlm.nih.gov/pubmed/29766636 http://dx.doi.org/10.1111/dom.13352 |
work_keys_str_mv | AT kawamoriryuzo empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT hanedamasakazu empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT suzakikeiko empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT chenggang empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT shikikosuke empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT miyamotoyuki empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT solimandofernando empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT leechristopher empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT leejisoo empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial AT georgejyothis empagliflozinasaddontolinagliptininafixeddosecombinationinjapanesepatientswithtype2diabetesglycaemicefficacyandsafetyprofileina52weekrandomizedplacebocontrolledtrial |