Tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese, Korean patients with type 2 diabetes

Sun Ok Song, Kwang Joon Kim, byungwan lee, Eun Seok Kang, Bong Soo Cha, Hyun Chul Lee

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11 Citations (Scopus)

Abstract

Aims/Introduction: We assessed the tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese Korean participants with type 2 diabetes. We also evaluated the characteristics of participants who respond adequately to glucagon-like peptide-1 (GLP-1) analog therapy in terms of glycated hemoglobin (HbA1c) level reductions and weight loss. Materials and Methods: This prospective, observational, single-arm (exenatide b.i.d. in combination with both metformin and sulphonylurea), open-label study of GLP-1 analog treatment with close monitoring of metabolic parameters and weight changes was carried out for up to 22 weeks. Results: Of the 110 enrolled obese participants, 37 participants dropped out during the 22-week treatment period. A total of 73 participants completed the study (median age 55.0 years, interquartile range 44.0-65.0). The median duration of diabetes was 8.0 years (interquartile range 3.5-12.5) with a mean HbA1c value of 7.6% (interquartile range 7.00-8.55). The median body mass index was 30.78 kg/m2 (interquartile range 27.89-33.92). After 22 weeks, median changes from baseline for HbA1c levels and weight were -0.7% and -3.0 kg, respectively, which were significant. No severe hypoglycemic events were observed. Multivariate regression analysis showed that C-peptide values were a significant independent predictor for a reduction in HbA1c levels (β = 0.865, P = 0.018) with exenatide BID in combination with both sulphonylurea and metformin in obese Korean participants with type 2 diabetes and insulin naïveté. Conclusions: Clinical and laboratory parameters, such as insulin naïveté and preserved β-cell function, should be taken into consideration as important factors in the choice of GLP-1 analog when predicting GLP-1 analog responsiveness. This trial was registered with the local committee at Yonsei University in Korea (4-2011-0032).

Original languageEnglish
Pages (from-to)554-562
Number of pages9
JournalJournal of Diabetes Investigation
Volume5
Issue number5
DOIs
Publication statusPublished - 2014 Jan 1

Fingerprint

Glucagon-Like Peptide 1
Type 2 Diabetes Mellitus
Metformin
Insulin
Weights and Measures
C-Peptide
Glycosylated Hemoglobin A
Therapeutics
Korea
Hypoglycemic Agents
Weight Loss
Body Mass Index
Multivariate Analysis
Regression Analysis
exenatide

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Internal Medicine

Cite this

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title = "Tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese, Korean patients with type 2 diabetes",
abstract = "Aims/Introduction: We assessed the tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese Korean participants with type 2 diabetes. We also evaluated the characteristics of participants who respond adequately to glucagon-like peptide-1 (GLP-1) analog therapy in terms of glycated hemoglobin (HbA1c) level reductions and weight loss. Materials and Methods: This prospective, observational, single-arm (exenatide b.i.d. in combination with both metformin and sulphonylurea), open-label study of GLP-1 analog treatment with close monitoring of metabolic parameters and weight changes was carried out for up to 22 weeks. Results: Of the 110 enrolled obese participants, 37 participants dropped out during the 22-week treatment period. A total of 73 participants completed the study (median age 55.0 years, interquartile range 44.0-65.0). The median duration of diabetes was 8.0 years (interquartile range 3.5-12.5) with a mean HbA1c value of 7.6{\%} (interquartile range 7.00-8.55). The median body mass index was 30.78 kg/m2 (interquartile range 27.89-33.92). After 22 weeks, median changes from baseline for HbA1c levels and weight were -0.7{\%} and -3.0 kg, respectively, which were significant. No severe hypoglycemic events were observed. Multivariate regression analysis showed that C-peptide values were a significant independent predictor for a reduction in HbA1c levels (β = 0.865, P = 0.018) with exenatide BID in combination with both sulphonylurea and metformin in obese Korean participants with type 2 diabetes and insulin na{\"i}vet{\'e}. Conclusions: Clinical and laboratory parameters, such as insulin na{\"i}vet{\'e} and preserved β-cell function, should be taken into consideration as important factors in the choice of GLP-1 analog when predicting GLP-1 analog responsiveness. This trial was registered with the local committee at Yonsei University in Korea (4-2011-0032).",
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Tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese, Korean patients with type 2 diabetes. / Song, Sun Ok; Kim, Kwang Joon; lee, byungwan; Kang, Eun Seok; Cha, Bong Soo; Lee, Hyun Chul.

In: Journal of Diabetes Investigation, Vol. 5, No. 5, 01.01.2014, p. 554-562.

Research output: Contribution to journalArticle

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AB - Aims/Introduction: We assessed the tolerability, effectiveness and predictive parameters for the therapeutic usefulness of exenatide in obese Korean participants with type 2 diabetes. We also evaluated the characteristics of participants who respond adequately to glucagon-like peptide-1 (GLP-1) analog therapy in terms of glycated hemoglobin (HbA1c) level reductions and weight loss. Materials and Methods: This prospective, observational, single-arm (exenatide b.i.d. in combination with both metformin and sulphonylurea), open-label study of GLP-1 analog treatment with close monitoring of metabolic parameters and weight changes was carried out for up to 22 weeks. Results: Of the 110 enrolled obese participants, 37 participants dropped out during the 22-week treatment period. A total of 73 participants completed the study (median age 55.0 years, interquartile range 44.0-65.0). The median duration of diabetes was 8.0 years (interquartile range 3.5-12.5) with a mean HbA1c value of 7.6% (interquartile range 7.00-8.55). The median body mass index was 30.78 kg/m2 (interquartile range 27.89-33.92). After 22 weeks, median changes from baseline for HbA1c levels and weight were -0.7% and -3.0 kg, respectively, which were significant. No severe hypoglycemic events were observed. Multivariate regression analysis showed that C-peptide values were a significant independent predictor for a reduction in HbA1c levels (β = 0.865, P = 0.018) with exenatide BID in combination with both sulphonylurea and metformin in obese Korean participants with type 2 diabetes and insulin naïveté. Conclusions: Clinical and laboratory parameters, such as insulin naïveté and preserved β-cell function, should be taken into consideration as important factors in the choice of GLP-1 analog when predicting GLP-1 analog responsiveness. This trial was registered with the local committee at Yonsei University in Korea (4-2011-0032).

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