Cargando…

Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes

INTRODUCTION: This analysis investigated the relationship between baseline fasting pancreatic β-cell function and efficacy in Japanese patients with type 2 diabetes (T2D) treated with once-weekly dulaglutide 0.75 mg (dulaglutide) or once-daily liraglutide 0.9 mg (liraglutide) for up to 52 weeks. MET...

Descripción completa

Detalles Bibliográficos
Autores principales: Iwamoto, Noriyuki, Matsui, Akiko, Kazama, Hirotaka, Oura, Tomonori
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801232/
https://www.ncbi.nlm.nih.gov/pubmed/29264713
http://dx.doi.org/10.1007/s13300-017-0346-4
_version_ 1783298311885684736
author Iwamoto, Noriyuki
Matsui, Akiko
Kazama, Hirotaka
Oura, Tomonori
author_facet Iwamoto, Noriyuki
Matsui, Akiko
Kazama, Hirotaka
Oura, Tomonori
author_sort Iwamoto, Noriyuki
collection PubMed
description INTRODUCTION: This analysis investigated the relationship between baseline fasting pancreatic β-cell function and efficacy in Japanese patients with type 2 diabetes (T2D) treated with once-weekly dulaglutide 0.75 mg (dulaglutide) or once-daily liraglutide 0.9 mg (liraglutide) for up to 52 weeks. METHODS: In a 52-week study of monotherapy in Japanese patients with T2D, patients were categorized into three subgroups defined by tertiles (low, medium, and high) of baseline values of three pancreatic β-cell function parameters [fasting C-peptide, C-peptide index, and secretory units of islets in transplantation (SUIT) index]. Associations between these parameters and efficacy [defined by changes from baseline in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), postprandial blood glucose (PBG), mean of all meals blood glucose excursion, and body weight] in the dulaglutide group (280 patients) or the liraglutide group (137 patients) were evaluated. RESULTS: Patients in the subgroups with high insulin-secreting ability (based on pancreatic β-cell function) were younger and had shorter disease duration and higher body mass index compared to those with low insulin-secreting ability. No specific trend was observed between baseline pancreatic β-cell function and changes in HbA1c or FBG. Reductions from baseline in mean PBG and excursion were greatest for patients in the low β-cell function tertiles. Inconsistent trends in body weight were observed across the treatment groups and β-cell function parameters. CONCLUSION: In Japanese patients with T2D, changes in HbA1c and body weight after 52 weeks of treatment with dulaglutide or liraglutide could not be predicted by patients’ fasting pancreatic β-cell function before treatment. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01558271). FUNDING: Eli Lilly K.K. (Kobe, Japan).
format Online
Article
Text
id pubmed-5801232
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-58012322018-02-12 Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes Iwamoto, Noriyuki Matsui, Akiko Kazama, Hirotaka Oura, Tomonori Diabetes Ther Brief Report INTRODUCTION: This analysis investigated the relationship between baseline fasting pancreatic β-cell function and efficacy in Japanese patients with type 2 diabetes (T2D) treated with once-weekly dulaglutide 0.75 mg (dulaglutide) or once-daily liraglutide 0.9 mg (liraglutide) for up to 52 weeks. METHODS: In a 52-week study of monotherapy in Japanese patients with T2D, patients were categorized into three subgroups defined by tertiles (low, medium, and high) of baseline values of three pancreatic β-cell function parameters [fasting C-peptide, C-peptide index, and secretory units of islets in transplantation (SUIT) index]. Associations between these parameters and efficacy [defined by changes from baseline in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), postprandial blood glucose (PBG), mean of all meals blood glucose excursion, and body weight] in the dulaglutide group (280 patients) or the liraglutide group (137 patients) were evaluated. RESULTS: Patients in the subgroups with high insulin-secreting ability (based on pancreatic β-cell function) were younger and had shorter disease duration and higher body mass index compared to those with low insulin-secreting ability. No specific trend was observed between baseline pancreatic β-cell function and changes in HbA1c or FBG. Reductions from baseline in mean PBG and excursion were greatest for patients in the low β-cell function tertiles. Inconsistent trends in body weight were observed across the treatment groups and β-cell function parameters. CONCLUSION: In Japanese patients with T2D, changes in HbA1c and body weight after 52 weeks of treatment with dulaglutide or liraglutide could not be predicted by patients’ fasting pancreatic β-cell function before treatment. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01558271). FUNDING: Eli Lilly K.K. (Kobe, Japan). Springer Healthcare 2017-12-20 2018-02 /pmc/articles/PMC5801232/ /pubmed/29264713 http://dx.doi.org/10.1007/s13300-017-0346-4 Text en © The Author(s) 2017 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Brief Report
Iwamoto, Noriyuki
Matsui, Akiko
Kazama, Hirotaka
Oura, Tomonori
Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes
title Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes
title_full Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes
title_fullStr Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes
title_full_unstemmed Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes
title_short Subgroup Analysis Stratified by Baseline Pancreatic β-cell Function in a Japanese Study of Dulaglutide in Patients with Type 2 Diabetes
title_sort subgroup analysis stratified by baseline pancreatic β-cell function in a japanese study of dulaglutide in patients with type 2 diabetes
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801232/
https://www.ncbi.nlm.nih.gov/pubmed/29264713
http://dx.doi.org/10.1007/s13300-017-0346-4
work_keys_str_mv AT iwamotonoriyuki subgroupanalysisstratifiedbybaselinepancreaticbcellfunctioninajapanesestudyofdulaglutideinpatientswithtype2diabetes
AT matsuiakiko subgroupanalysisstratifiedbybaselinepancreaticbcellfunctioninajapanesestudyofdulaglutideinpatientswithtype2diabetes
AT kazamahirotaka subgroupanalysisstratifiedbybaselinepancreaticbcellfunctioninajapanesestudyofdulaglutideinpatientswithtype2diabetes
AT ouratomonori subgroupanalysisstratifiedbybaselinepancreaticbcellfunctioninajapanesestudyofdulaglutideinpatientswithtype2diabetes