Comparison of the effects of gemigliptin and dapagliflozin on glycaemic variability in type 2 diabetes: A randomized, open-label, active-controlled, 12-week study (STABLE II study)

Soo Heon Kwak, You Cheol Hwang, Jong Chul Won, Ji Cheol Bae, Hyun Jin Kim, Sunghwan Suh, Eun Young Lee, Subin Lee, Sang Yong Kim, Jae Hyeon Kim

Research output: Contribution to journalArticle

Abstract

Aims: The aim of this study was to compare the effect of gemigliptin, a dipeptidyl peptidase-4 inhibitor, and dapagliflozin, a sodium glucose co-transporter-2 inhibitor, on glycaemic variability in type 2 diabetes patients. Materials and methods: In this randomized, blinded end point, multicentre clinical trial, we enrolled 71 patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve. The participants were randomized to receive gemigliptin 50 mg (n = 35) or dapagliflozin 10 mg (n = 36) daily for 12 weeks. Glycaemic variability was estimated by mean amplitude of glycaemic excursions (MAGE), standard deviation (SD) and coefficient of variation (CV) using a 6-day continuous glucose monitoring system. The primary efficacy endpoint was change in MAGE after 12 weeks compared to baseline. Results: Intergroup differences in baseline characteristics were not significant. The adjusted mean change (± standard error) in MAGE after 12 weeks in the gemigliptin and dapagliflozin groups was −27.2 ± 4.4 mg/dL and −7.9 ± 4.9 mg/dL, respectively. Between-group comparisons showed a significantly larger reduction in MAGE in the gemigliptin group (−19.2 mg/dL; 95% CI, −31.3 to −7.2; P =.002). Measures of SD and CV also showed a significantly larger reduction in the gemigliptin group. Average glycaemic control, estimated by HbA1c, fasting glucose and safety profiles, was comparable between the two groups. Conclusions: Compared to dapagliflozin, gemigliptin significantly improved glycaemic variability, with similar glucose-lowering efficacy and safety profiles in patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve.

Original languageEnglish
Pages (from-to)173-181
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume22
Issue number2
DOIs
StatePublished - 1 Feb 2020

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Type 2 Diabetes Mellitus
Metformin
Glucose
Sodium-Glucose Transporter 2
Dipeptidyl-Peptidase IV Inhibitors
Symporters
Safety
Pharmaceutical Preparations
Multicenter Studies
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
LC15-0444
Fasting
Clinical Trials

Cite this

Kwak, Soo Heon ; Hwang, You Cheol ; Won, Jong Chul ; Bae, Ji Cheol ; Kim, Hyun Jin ; Suh, Sunghwan ; Lee, Eun Young ; Lee, Subin ; Kim, Sang Yong ; Kim, Jae Hyeon. / Comparison of the effects of gemigliptin and dapagliflozin on glycaemic variability in type 2 diabetes : A randomized, open-label, active-controlled, 12-week study (STABLE II study). In: Diabetes, Obesity and Metabolism. 2020 ; Vol. 22, No. 2. pp. 173-181.
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abstract = "Aims: The aim of this study was to compare the effect of gemigliptin, a dipeptidyl peptidase-4 inhibitor, and dapagliflozin, a sodium glucose co-transporter-2 inhibitor, on glycaemic variability in type 2 diabetes patients. Materials and methods: In this randomized, blinded end point, multicentre clinical trial, we enrolled 71 patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug na{\"i}ve. The participants were randomized to receive gemigliptin 50 mg (n = 35) or dapagliflozin 10 mg (n = 36) daily for 12 weeks. Glycaemic variability was estimated by mean amplitude of glycaemic excursions (MAGE), standard deviation (SD) and coefficient of variation (CV) using a 6-day continuous glucose monitoring system. The primary efficacy endpoint was change in MAGE after 12 weeks compared to baseline. Results: Intergroup differences in baseline characteristics were not significant. The adjusted mean change (± standard error) in MAGE after 12 weeks in the gemigliptin and dapagliflozin groups was −27.2 ± 4.4 mg/dL and −7.9 ± 4.9 mg/dL, respectively. Between-group comparisons showed a significantly larger reduction in MAGE in the gemigliptin group (−19.2 mg/dL; 95{\%} CI, −31.3 to −7.2; P =.002). Measures of SD and CV also showed a significantly larger reduction in the gemigliptin group. Average glycaemic control, estimated by HbA1c, fasting glucose and safety profiles, was comparable between the two groups. Conclusions: Compared to dapagliflozin, gemigliptin significantly improved glycaemic variability, with similar glucose-lowering efficacy and safety profiles in patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug na{\"i}ve.",
author = "Kwak, {Soo Heon} and Hwang, {You Cheol} and Won, {Jong Chul} and Bae, {Ji Cheol} and Kim, {Hyun Jin} and Sunghwan Suh and Lee, {Eun Young} and Subin Lee and Kim, {Sang Yong} and Kim, {Jae Hyeon}",
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Comparison of the effects of gemigliptin and dapagliflozin on glycaemic variability in type 2 diabetes : A randomized, open-label, active-controlled, 12-week study (STABLE II study). / Kwak, Soo Heon; Hwang, You Cheol; Won, Jong Chul; Bae, Ji Cheol; Kim, Hyun Jin; Suh, Sunghwan; Lee, Eun Young; Lee, Subin; Kim, Sang Yong; Kim, Jae Hyeon.

In: Diabetes, Obesity and Metabolism, Vol. 22, No. 2, 01.02.2020, p. 173-181.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison of the effects of gemigliptin and dapagliflozin on glycaemic variability in type 2 diabetes

T2 - A randomized, open-label, active-controlled, 12-week study (STABLE II study)

AU - Kwak, Soo Heon

AU - Hwang, You Cheol

AU - Won, Jong Chul

AU - Bae, Ji Cheol

AU - Kim, Hyun Jin

AU - Suh, Sunghwan

AU - Lee, Eun Young

AU - Lee, Subin

AU - Kim, Sang Yong

AU - Kim, Jae Hyeon

PY - 2020/2/1

Y1 - 2020/2/1

N2 - Aims: The aim of this study was to compare the effect of gemigliptin, a dipeptidyl peptidase-4 inhibitor, and dapagliflozin, a sodium glucose co-transporter-2 inhibitor, on glycaemic variability in type 2 diabetes patients. Materials and methods: In this randomized, blinded end point, multicentre clinical trial, we enrolled 71 patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve. The participants were randomized to receive gemigliptin 50 mg (n = 35) or dapagliflozin 10 mg (n = 36) daily for 12 weeks. Glycaemic variability was estimated by mean amplitude of glycaemic excursions (MAGE), standard deviation (SD) and coefficient of variation (CV) using a 6-day continuous glucose monitoring system. The primary efficacy endpoint was change in MAGE after 12 weeks compared to baseline. Results: Intergroup differences in baseline characteristics were not significant. The adjusted mean change (± standard error) in MAGE after 12 weeks in the gemigliptin and dapagliflozin groups was −27.2 ± 4.4 mg/dL and −7.9 ± 4.9 mg/dL, respectively. Between-group comparisons showed a significantly larger reduction in MAGE in the gemigliptin group (−19.2 mg/dL; 95% CI, −31.3 to −7.2; P =.002). Measures of SD and CV also showed a significantly larger reduction in the gemigliptin group. Average glycaemic control, estimated by HbA1c, fasting glucose and safety profiles, was comparable between the two groups. Conclusions: Compared to dapagliflozin, gemigliptin significantly improved glycaemic variability, with similar glucose-lowering efficacy and safety profiles in patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve.

AB - Aims: The aim of this study was to compare the effect of gemigliptin, a dipeptidyl peptidase-4 inhibitor, and dapagliflozin, a sodium glucose co-transporter-2 inhibitor, on glycaemic variability in type 2 diabetes patients. Materials and methods: In this randomized, blinded end point, multicentre clinical trial, we enrolled 71 patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve. The participants were randomized to receive gemigliptin 50 mg (n = 35) or dapagliflozin 10 mg (n = 36) daily for 12 weeks. Glycaemic variability was estimated by mean amplitude of glycaemic excursions (MAGE), standard deviation (SD) and coefficient of variation (CV) using a 6-day continuous glucose monitoring system. The primary efficacy endpoint was change in MAGE after 12 weeks compared to baseline. Results: Intergroup differences in baseline characteristics were not significant. The adjusted mean change (± standard error) in MAGE after 12 weeks in the gemigliptin and dapagliflozin groups was −27.2 ± 4.4 mg/dL and −7.9 ± 4.9 mg/dL, respectively. Between-group comparisons showed a significantly larger reduction in MAGE in the gemigliptin group (−19.2 mg/dL; 95% CI, −31.3 to −7.2; P =.002). Measures of SD and CV also showed a significantly larger reduction in the gemigliptin group. Average glycaemic control, estimated by HbA1c, fasting glucose and safety profiles, was comparable between the two groups. Conclusions: Compared to dapagliflozin, gemigliptin significantly improved glycaemic variability, with similar glucose-lowering efficacy and safety profiles in patients with type 2 diabetes who were inadequately controlled with metformin alone or were drug naïve.

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