Efficacy and safety of once-weekly exenatide after switching from twice-daily exenatide in patients with type 2 diabetes

for the Twin-exenatide Study Group

Research output: Contribution to journalArticle

Abstract

Aims/Introduction: To evaluate the efficacy and safety of once-weekly (q.w.) extended-release exenatide after switching from twice-daily (b.i.d.) exenatide in patients with type 2 diabetes. Materials and Methods: This was an investigator-initiated, prospective, single-arm, multicenter study. Individuals with type 2 diabetes who had been treated with exenatide b.i.d. for at least 3 months were enrolled and switched to exenatide q.w. for 24 weeks. The primary end-point was change in HbA1c at week 24 to test the glucose-lowering effect of exenatide q.w. versus exenatide b.i.d. Results: A total of 58 Japanese individuals with type 2 diabetes completed the study. Glycated hemoglobin was reduced by 0.2% at week 24 (7.2 ± 1.2% vs 7.0 ± 1.2% [56 ± 13 vs 53 ± 13 mmol/mol], 95% confidence interval −0.4 to −0.03%, P < 0.005 for non-inferiority, P = 0.01 for superiority). Fasting plasma glucose was reduced by 12 mg/dL at week 24 (154 ± 46 vs 142 ± 46 mg/dL, P = 0.02). β-Cell function assessed by homeostasis model assessment of β-cell function and C-peptide index was significantly improved at week 24. The incidence of self-reported hypoglycemia was reduced, and treatment satisfaction assessed by the Diabetes Treatment Satisfaction Questionnaire and Diabetes Medication Satisfaction Questionnaire was improved at week 24, with no change in body weight. There was no serious adverse event related to the study drug. Conclusions: Switching from exenatide b.i.d. to exenatide q.w. resulted in a reduction in glycated hemoglobin, fasting plasma glucose and the incidence of hypoglycemia, and improvement in β-cell function and treatment satisfaction in patients with type 2 diabetes. These findings will be useful for selecting optimal treatment in individuals with type 2 diabetes.

Original languageEnglish
JournalJournal of Diabetes Investigation
DOIs
Publication statusAccepted/In press - 2019 Jan 1

Fingerprint

Safety
Glycosylated Hemoglobin A
Hypoglycemia
Glucose
Fasting
exenatide
C-Peptide
Incidence
Therapeutics
Patient Satisfaction
Multicenter Studies
Homeostasis
Research Personnel
Confidence Intervals
Pharmaceutical Preparations
Surveys and Questionnaires

Keywords

  • Glucagon-like peptide-1 receptor agonist
  • Treatment satisfaction
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Efficacy and safety of once-weekly exenatide after switching from twice-daily exenatide in patients with type 2 diabetes. / for the Twin-exenatide Study Group.

In: Journal of Diabetes Investigation, 01.01.2019.

Research output: Contribution to journalArticle

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title = "Efficacy and safety of once-weekly exenatide after switching from twice-daily exenatide in patients with type 2 diabetes",
abstract = "Aims/Introduction: To evaluate the efficacy and safety of once-weekly (q.w.) extended-release exenatide after switching from twice-daily (b.i.d.) exenatide in patients with type 2 diabetes. Materials and Methods: This was an investigator-initiated, prospective, single-arm, multicenter study. Individuals with type 2 diabetes who had been treated with exenatide b.i.d. for at least 3 months were enrolled and switched to exenatide q.w. for 24 weeks. The primary end-point was change in HbA1c at week 24 to test the glucose-lowering effect of exenatide q.w. versus exenatide b.i.d. Results: A total of 58 Japanese individuals with type 2 diabetes completed the study. Glycated hemoglobin was reduced by 0.2{\%} at week 24 (7.2 ± 1.2{\%} vs 7.0 ± 1.2{\%} [56 ± 13 vs 53 ± 13 mmol/mol], 95{\%} confidence interval −0.4 to −0.03{\%}, P < 0.005 for non-inferiority, P = 0.01 for superiority). Fasting plasma glucose was reduced by 12 mg/dL at week 24 (154 ± 46 vs 142 ± 46 mg/dL, P = 0.02). β-Cell function assessed by homeostasis model assessment of β-cell function and C-peptide index was significantly improved at week 24. The incidence of self-reported hypoglycemia was reduced, and treatment satisfaction assessed by the Diabetes Treatment Satisfaction Questionnaire and Diabetes Medication Satisfaction Questionnaire was improved at week 24, with no change in body weight. There was no serious adverse event related to the study drug. Conclusions: Switching from exenatide b.i.d. to exenatide q.w. resulted in a reduction in glycated hemoglobin, fasting plasma glucose and the incidence of hypoglycemia, and improvement in β-cell function and treatment satisfaction in patients with type 2 diabetes. These findings will be useful for selecting optimal treatment in individuals with type 2 diabetes.",
keywords = "Glucagon-like peptide-1 receptor agonist, Treatment satisfaction, Type 2 diabetes",
author = "{for the Twin-exenatide Study Group} and Yuusuke Watanabe and Yoshifumi Saisho and Jun Inaishi and Kinsei Kou and Akira Yamauchi and Yasuhiko Kanazawa and Yoshiaki Okubo and Mikiya Tokui and Takatoshi Imai and Rie Murakami and Tami Tsuchiya and Hironobu Sasaki and Tatsuhiro Masaoka and Junichiro Irie and Shu Meguro and Hiroshi Itoh",
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T1 - Efficacy and safety of once-weekly exenatide after switching from twice-daily exenatide in patients with type 2 diabetes

AU - for the Twin-exenatide Study Group

AU - Watanabe, Yuusuke

AU - Saisho, Yoshifumi

AU - Inaishi, Jun

AU - Kou, Kinsei

AU - Yamauchi, Akira

AU - Kanazawa, Yasuhiko

AU - Okubo, Yoshiaki

AU - Tokui, Mikiya

AU - Imai, Takatoshi

AU - Murakami, Rie

AU - Tsuchiya, Tami

AU - Sasaki, Hironobu

AU - Masaoka, Tatsuhiro

AU - Irie, Junichiro

AU - Meguro, Shu

AU - Itoh, Hiroshi

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Aims/Introduction: To evaluate the efficacy and safety of once-weekly (q.w.) extended-release exenatide after switching from twice-daily (b.i.d.) exenatide in patients with type 2 diabetes. Materials and Methods: This was an investigator-initiated, prospective, single-arm, multicenter study. Individuals with type 2 diabetes who had been treated with exenatide b.i.d. for at least 3 months were enrolled and switched to exenatide q.w. for 24 weeks. The primary end-point was change in HbA1c at week 24 to test the glucose-lowering effect of exenatide q.w. versus exenatide b.i.d. Results: A total of 58 Japanese individuals with type 2 diabetes completed the study. Glycated hemoglobin was reduced by 0.2% at week 24 (7.2 ± 1.2% vs 7.0 ± 1.2% [56 ± 13 vs 53 ± 13 mmol/mol], 95% confidence interval −0.4 to −0.03%, P < 0.005 for non-inferiority, P = 0.01 for superiority). Fasting plasma glucose was reduced by 12 mg/dL at week 24 (154 ± 46 vs 142 ± 46 mg/dL, P = 0.02). β-Cell function assessed by homeostasis model assessment of β-cell function and C-peptide index was significantly improved at week 24. The incidence of self-reported hypoglycemia was reduced, and treatment satisfaction assessed by the Diabetes Treatment Satisfaction Questionnaire and Diabetes Medication Satisfaction Questionnaire was improved at week 24, with no change in body weight. There was no serious adverse event related to the study drug. Conclusions: Switching from exenatide b.i.d. to exenatide q.w. resulted in a reduction in glycated hemoglobin, fasting plasma glucose and the incidence of hypoglycemia, and improvement in β-cell function and treatment satisfaction in patients with type 2 diabetes. These findings will be useful for selecting optimal treatment in individuals with type 2 diabetes.

AB - Aims/Introduction: To evaluate the efficacy and safety of once-weekly (q.w.) extended-release exenatide after switching from twice-daily (b.i.d.) exenatide in patients with type 2 diabetes. Materials and Methods: This was an investigator-initiated, prospective, single-arm, multicenter study. Individuals with type 2 diabetes who had been treated with exenatide b.i.d. for at least 3 months were enrolled and switched to exenatide q.w. for 24 weeks. The primary end-point was change in HbA1c at week 24 to test the glucose-lowering effect of exenatide q.w. versus exenatide b.i.d. Results: A total of 58 Japanese individuals with type 2 diabetes completed the study. Glycated hemoglobin was reduced by 0.2% at week 24 (7.2 ± 1.2% vs 7.0 ± 1.2% [56 ± 13 vs 53 ± 13 mmol/mol], 95% confidence interval −0.4 to −0.03%, P < 0.005 for non-inferiority, P = 0.01 for superiority). Fasting plasma glucose was reduced by 12 mg/dL at week 24 (154 ± 46 vs 142 ± 46 mg/dL, P = 0.02). β-Cell function assessed by homeostasis model assessment of β-cell function and C-peptide index was significantly improved at week 24. The incidence of self-reported hypoglycemia was reduced, and treatment satisfaction assessed by the Diabetes Treatment Satisfaction Questionnaire and Diabetes Medication Satisfaction Questionnaire was improved at week 24, with no change in body weight. There was no serious adverse event related to the study drug. Conclusions: Switching from exenatide b.i.d. to exenatide q.w. resulted in a reduction in glycated hemoglobin, fasting plasma glucose and the incidence of hypoglycemia, and improvement in β-cell function and treatment satisfaction in patients with type 2 diabetes. These findings will be useful for selecting optimal treatment in individuals with type 2 diabetes.

KW - Glucagon-like peptide-1 receptor agonist

KW - Treatment satisfaction

KW - Type 2 diabetes

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