Efficacy and safety of dulaglutide monotherapy compared with glimepiride in East-Asian patients with type 2 diabetes in a multicentre, double-blind, randomized, parallel-arm, active comparator, phase III trial

Yu Hong Chen, Chien Ning Huang, Young Min Cho, Pengfei Li, Liqun Gu, Feng Wang, Jun Yang, Wei Qing Wang

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Abstract

Aims: To compare the efficacy and safety of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide 1.5 and 0.75 mg with glimepiride in East-Asian patients with type 2 diabetes (T2D). Materials and methods: In this phase III, multinational, multicentre, double-blind, randomized, parallel-arm, 26-week study, patients with inadequate glycaemic control were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or daily glimepiride (1-3 mg/d). The primary endpoint was assessment of the non-inferiority of dulaglutide (1.5 mg), as measured by change in glycated haemoglobin (HbA1c), compared with glimepiride using a 0.4% non-inferiority margin. Results: A total of 737 patients were randomized (dulaglutide 1.5 mg, n = 244; dulaglutide 0.75 mg, n = 248; glimepiride, n = 245). At week 26, both doses of dulaglutide were non-inferior and also superior to glimepiride for HbA1c reduction from baseline with a least squares mean difference of −6.34 mmol/mol (95% confidence interval [CI] −8.31, −4.26) or -0.58% (95% CI −0.76, −0.39) for dulaglutide 1.5 mg and −3.50 mmol/mol (95% CI −5.47, −1.42) or −0.32% (95% CI −0.50, −0.13) for dulaglutide 0.75 mg (P <.001). A greater proportion of patients in the dulaglutide 1.5 mg group achieved the HbA1c target of <53 mmol/mol (<7.0%) compared with the glimepiride group (74.1% vs 57.4%; P <.001). The mean body weight decreased (P <.005) and total hypoglycaemia rates were lower (P <.001) in the dulaglutide groups compared with the glimepiride group. The most common drug-related adverse events in both dulaglutide groups (≥5% of patients) included diarrhoea, nausea, increased lipase, decreased appetite, abdominal distension and vomiting. Conclusions: Dulaglutide (both doses) demonstrated superior glycaemic control vs glimepiride, with a favourable tolerability and safety profile in East-Asian patients with T2D.

Original languageEnglish
Pages (from-to)2121-2130
Number of pages10
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number9
DOIs
StatePublished - 1 Sep 2018

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glimepiride
Type 2 Diabetes Mellitus
Safety
Confidence Intervals
dulaglutide

Keywords

  • HbA1c
  • dulaglutide
  • glimepiride
  • glucagon-like peptide-1 receptor agonist
  • type 2 diabetes

Cite this

@article{222606d9b3fb4f8484a3e77f416846e6,
title = "Efficacy and safety of dulaglutide monotherapy compared with glimepiride in East-Asian patients with type 2 diabetes in a multicentre, double-blind, randomized, parallel-arm, active comparator, phase III trial",
abstract = "Aims: To compare the efficacy and safety of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide 1.5 and 0.75 mg with glimepiride in East-Asian patients with type 2 diabetes (T2D). Materials and methods: In this phase III, multinational, multicentre, double-blind, randomized, parallel-arm, 26-week study, patients with inadequate glycaemic control were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or daily glimepiride (1-3 mg/d). The primary endpoint was assessment of the non-inferiority of dulaglutide (1.5 mg), as measured by change in glycated haemoglobin (HbA1c), compared with glimepiride using a 0.4{\%} non-inferiority margin. Results: A total of 737 patients were randomized (dulaglutide 1.5 mg, n = 244; dulaglutide 0.75 mg, n = 248; glimepiride, n = 245). At week 26, both doses of dulaglutide were non-inferior and also superior to glimepiride for HbA1c reduction from baseline with a least squares mean difference of −6.34 mmol/mol (95{\%} confidence interval [CI] −8.31, −4.26) or -0.58{\%} (95{\%} CI −0.76, −0.39) for dulaglutide 1.5 mg and −3.50 mmol/mol (95{\%} CI −5.47, −1.42) or −0.32{\%} (95{\%} CI −0.50, −0.13) for dulaglutide 0.75 mg (P <.001). A greater proportion of patients in the dulaglutide 1.5 mg group achieved the HbA1c target of <53 mmol/mol (<7.0{\%}) compared with the glimepiride group (74.1{\%} vs 57.4{\%}; P <.001). The mean body weight decreased (P <.005) and total hypoglycaemia rates were lower (P <.001) in the dulaglutide groups compared with the glimepiride group. The most common drug-related adverse events in both dulaglutide groups (≥5{\%} of patients) included diarrhoea, nausea, increased lipase, decreased appetite, abdominal distension and vomiting. Conclusions: Dulaglutide (both doses) demonstrated superior glycaemic control vs glimepiride, with a favourable tolerability and safety profile in East-Asian patients with T2D.",
keywords = "HbA1c, dulaglutide, glimepiride, glucagon-like peptide-1 receptor agonist, type 2 diabetes",
author = "Chen, {Yu Hong} and Huang, {Chien Ning} and Cho, {Young Min} and Pengfei Li and Liqun Gu and Feng Wang and Jun Yang and Wang, {Wei Qing}",
year = "2018",
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day = "1",
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Efficacy and safety of dulaglutide monotherapy compared with glimepiride in East-Asian patients with type 2 diabetes in a multicentre, double-blind, randomized, parallel-arm, active comparator, phase III trial. / Chen, Yu Hong; Huang, Chien Ning; Cho, Young Min; Li, Pengfei; Gu, Liqun; Wang, Feng; Yang, Jun; Wang, Wei Qing.

In: Diabetes, Obesity and Metabolism, Vol. 20, No. 9, 01.09.2018, p. 2121-2130.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of dulaglutide monotherapy compared with glimepiride in East-Asian patients with type 2 diabetes in a multicentre, double-blind, randomized, parallel-arm, active comparator, phase III trial

AU - Chen, Yu Hong

AU - Huang, Chien Ning

AU - Cho, Young Min

AU - Li, Pengfei

AU - Gu, Liqun

AU - Wang, Feng

AU - Yang, Jun

AU - Wang, Wei Qing

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Aims: To compare the efficacy and safety of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide 1.5 and 0.75 mg with glimepiride in East-Asian patients with type 2 diabetes (T2D). Materials and methods: In this phase III, multinational, multicentre, double-blind, randomized, parallel-arm, 26-week study, patients with inadequate glycaemic control were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or daily glimepiride (1-3 mg/d). The primary endpoint was assessment of the non-inferiority of dulaglutide (1.5 mg), as measured by change in glycated haemoglobin (HbA1c), compared with glimepiride using a 0.4% non-inferiority margin. Results: A total of 737 patients were randomized (dulaglutide 1.5 mg, n = 244; dulaglutide 0.75 mg, n = 248; glimepiride, n = 245). At week 26, both doses of dulaglutide were non-inferior and also superior to glimepiride for HbA1c reduction from baseline with a least squares mean difference of −6.34 mmol/mol (95% confidence interval [CI] −8.31, −4.26) or -0.58% (95% CI −0.76, −0.39) for dulaglutide 1.5 mg and −3.50 mmol/mol (95% CI −5.47, −1.42) or −0.32% (95% CI −0.50, −0.13) for dulaglutide 0.75 mg (P <.001). A greater proportion of patients in the dulaglutide 1.5 mg group achieved the HbA1c target of <53 mmol/mol (<7.0%) compared with the glimepiride group (74.1% vs 57.4%; P <.001). The mean body weight decreased (P <.005) and total hypoglycaemia rates were lower (P <.001) in the dulaglutide groups compared with the glimepiride group. The most common drug-related adverse events in both dulaglutide groups (≥5% of patients) included diarrhoea, nausea, increased lipase, decreased appetite, abdominal distension and vomiting. Conclusions: Dulaglutide (both doses) demonstrated superior glycaemic control vs glimepiride, with a favourable tolerability and safety profile in East-Asian patients with T2D.

AB - Aims: To compare the efficacy and safety of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide 1.5 and 0.75 mg with glimepiride in East-Asian patients with type 2 diabetes (T2D). Materials and methods: In this phase III, multinational, multicentre, double-blind, randomized, parallel-arm, 26-week study, patients with inadequate glycaemic control were randomized 1:1:1 to once-weekly dulaglutide 1.5 or 0.75 mg or daily glimepiride (1-3 mg/d). The primary endpoint was assessment of the non-inferiority of dulaglutide (1.5 mg), as measured by change in glycated haemoglobin (HbA1c), compared with glimepiride using a 0.4% non-inferiority margin. Results: A total of 737 patients were randomized (dulaglutide 1.5 mg, n = 244; dulaglutide 0.75 mg, n = 248; glimepiride, n = 245). At week 26, both doses of dulaglutide were non-inferior and also superior to glimepiride for HbA1c reduction from baseline with a least squares mean difference of −6.34 mmol/mol (95% confidence interval [CI] −8.31, −4.26) or -0.58% (95% CI −0.76, −0.39) for dulaglutide 1.5 mg and −3.50 mmol/mol (95% CI −5.47, −1.42) or −0.32% (95% CI −0.50, −0.13) for dulaglutide 0.75 mg (P <.001). A greater proportion of patients in the dulaglutide 1.5 mg group achieved the HbA1c target of <53 mmol/mol (<7.0%) compared with the glimepiride group (74.1% vs 57.4%; P <.001). The mean body weight decreased (P <.005) and total hypoglycaemia rates were lower (P <.001) in the dulaglutide groups compared with the glimepiride group. The most common drug-related adverse events in both dulaglutide groups (≥5% of patients) included diarrhoea, nausea, increased lipase, decreased appetite, abdominal distension and vomiting. Conclusions: Dulaglutide (both doses) demonstrated superior glycaemic control vs glimepiride, with a favourable tolerability and safety profile in East-Asian patients with T2D.

KW - HbA1c

KW - dulaglutide

KW - glimepiride

KW - glucagon-like peptide-1 receptor agonist

KW - type 2 diabetes

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DO - 10.1111/dom.13340

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