A 52-week extension study of switching from gemigliptin vs sitagliptin to gemigliptin only as add-on therapy for patients with type 2 diabetes who are inadequately controlled with metformin alone

for the Gemigliptin Study 006 Group

Research output: Contribution to journalArticle

Abstract

We investigated the long-term efficacy and safety of gemigliptin and the efficacy and safety of gemigliptin treatment after once-daily treatment with sitagliptin 100 mg, in patients with type 2 diabetes. This was a 28-week extension of a 24-week, randomized, double-blind, parallel study of gemigliptin or sitagliptin added to ongoing metformin therapy. After randomization to sitagliptin 100 mg qd (S), gemigliptin 25 mg bid (G1) or gemigliptin 50 mg qd (G2) and after completing 24 weeks of treatment, 118 patients switched from gemigliptin 25 mg bid to 50 mg qd (G1/G2), 111 patients continued gemigliptin 50 mg qd (G2/G2) and 106 patients switched from sitagliptin 100 mg qd to gemigliptin 50 mg qd (S/G2). All 3 treatments reduced glycated haemoglobin (HbA1c) (S/G2,−0.99% [95% CI −1.25%, −0.73%]; G1/G2, −1.11% [95% CI −1.33%, −0.89%]; G2/G2, −1.06% [95% CI −1.28%, −0.85%]). The percentage of patients achieving HbA1c < 6.5% was 27.6% in the G1/G2 group at both Week 24 and Week 52, and ranged from 27.3% to 32.7% in the G2/G2 group (difference in proportions, 5% [95% CI −6%, 17%]), while it increased from 6.8% to 27.3% from Week 24 to Week 52 in the S/G2 group (difference in proportions, 20% [95% CI 7%, 34%]). Addition of gemigliptin 50 mg qd to metformin was shown to be efficacious for 52 weeks. Switching from sitagliptin 100 mg to gemigliptin 50 mg showed consistent glyacemic control over the previous treatment.

Original languageEnglish
Pages (from-to)1535-1541
Number of pages7
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number6
DOIs
Publication statusPublished - 2018 Jun 1

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Metformin
Type 2 Diabetes Mellitus
Therapeutics
LC15-0444
Sitagliptin Phosphate
Sickle Hemoglobin
Safety
Glycosylated Hemoglobin A
Random Allocation
Double-Blind Method

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

@article{99b885b7d7c1433197197cba9e67503f,
title = "A 52-week extension study of switching from gemigliptin vs sitagliptin to gemigliptin only as add-on therapy for patients with type 2 diabetes who are inadequately controlled with metformin alone",
abstract = "We investigated the long-term efficacy and safety of gemigliptin and the efficacy and safety of gemigliptin treatment after once-daily treatment with sitagliptin 100 mg, in patients with type 2 diabetes. This was a 28-week extension of a 24-week, randomized, double-blind, parallel study of gemigliptin or sitagliptin added to ongoing metformin therapy. After randomization to sitagliptin 100 mg qd (S), gemigliptin 25 mg bid (G1) or gemigliptin 50 mg qd (G2) and after completing 24 weeks of treatment, 118 patients switched from gemigliptin 25 mg bid to 50 mg qd (G1/G2), 111 patients continued gemigliptin 50 mg qd (G2/G2) and 106 patients switched from sitagliptin 100 mg qd to gemigliptin 50 mg qd (S/G2). All 3 treatments reduced glycated haemoglobin (HbA1c) (S/G2,−0.99{\%} [95{\%} CI −1.25{\%}, −0.73{\%}]; G1/G2, −1.11{\%} [95{\%} CI −1.33{\%}, −0.89{\%}]; G2/G2, −1.06{\%} [95{\%} CI −1.28{\%}, −0.85{\%}]). The percentage of patients achieving HbA1c < 6.5{\%} was 27.6{\%} in the G1/G2 group at both Week 24 and Week 52, and ranged from 27.3{\%} to 32.7{\%} in the G2/G2 group (difference in proportions, 5{\%} [95{\%} CI −6{\%}, 17{\%}]), while it increased from 6.8{\%} to 27.3{\%} from Week 24 to Week 52 in the S/G2 group (difference in proportions, 20{\%} [95{\%} CI 7{\%}, 34{\%}]). Addition of gemigliptin 50 mg qd to metformin was shown to be efficacious for 52 weeks. Switching from sitagliptin 100 mg to gemigliptin 50 mg showed consistent glyacemic control over the previous treatment.",
author = "{for the Gemigliptin Study 006 Group} and Jung, {Chan Hee} and Rhee, {Eun Jung} and Lee, {Won Young} and Min, {Kyung Wan} and Shivane, {Vyankatesh K.} and Sosale, {Aravind R.} and Jang, {Hak Chul} and Chung, {Choon Hee} and Nam-Goong, {Il Seong}",
year = "2018",
month = "6",
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doi = "10.1111/dom.13256",
language = "English",
volume = "20",
pages = "1535--1541",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
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T1 - A 52-week extension study of switching from gemigliptin vs sitagliptin to gemigliptin only as add-on therapy for patients with type 2 diabetes who are inadequately controlled with metformin alone

AU - for the Gemigliptin Study 006 Group

AU - Jung, Chan Hee

AU - Rhee, Eun Jung

AU - Lee, Won Young

AU - Min, Kyung Wan

AU - Shivane, Vyankatesh K.

AU - Sosale, Aravind R.

AU - Jang, Hak Chul

AU - Chung, Choon Hee

AU - Nam-Goong, Il Seong

PY - 2018/6/1

Y1 - 2018/6/1

N2 - We investigated the long-term efficacy and safety of gemigliptin and the efficacy and safety of gemigliptin treatment after once-daily treatment with sitagliptin 100 mg, in patients with type 2 diabetes. This was a 28-week extension of a 24-week, randomized, double-blind, parallel study of gemigliptin or sitagliptin added to ongoing metformin therapy. After randomization to sitagliptin 100 mg qd (S), gemigliptin 25 mg bid (G1) or gemigliptin 50 mg qd (G2) and after completing 24 weeks of treatment, 118 patients switched from gemigliptin 25 mg bid to 50 mg qd (G1/G2), 111 patients continued gemigliptin 50 mg qd (G2/G2) and 106 patients switched from sitagliptin 100 mg qd to gemigliptin 50 mg qd (S/G2). All 3 treatments reduced glycated haemoglobin (HbA1c) (S/G2,−0.99% [95% CI −1.25%, −0.73%]; G1/G2, −1.11% [95% CI −1.33%, −0.89%]; G2/G2, −1.06% [95% CI −1.28%, −0.85%]). The percentage of patients achieving HbA1c < 6.5% was 27.6% in the G1/G2 group at both Week 24 and Week 52, and ranged from 27.3% to 32.7% in the G2/G2 group (difference in proportions, 5% [95% CI −6%, 17%]), while it increased from 6.8% to 27.3% from Week 24 to Week 52 in the S/G2 group (difference in proportions, 20% [95% CI 7%, 34%]). Addition of gemigliptin 50 mg qd to metformin was shown to be efficacious for 52 weeks. Switching from sitagliptin 100 mg to gemigliptin 50 mg showed consistent glyacemic control over the previous treatment.

AB - We investigated the long-term efficacy and safety of gemigliptin and the efficacy and safety of gemigliptin treatment after once-daily treatment with sitagliptin 100 mg, in patients with type 2 diabetes. This was a 28-week extension of a 24-week, randomized, double-blind, parallel study of gemigliptin or sitagliptin added to ongoing metformin therapy. After randomization to sitagliptin 100 mg qd (S), gemigliptin 25 mg bid (G1) or gemigliptin 50 mg qd (G2) and after completing 24 weeks of treatment, 118 patients switched from gemigliptin 25 mg bid to 50 mg qd (G1/G2), 111 patients continued gemigliptin 50 mg qd (G2/G2) and 106 patients switched from sitagliptin 100 mg qd to gemigliptin 50 mg qd (S/G2). All 3 treatments reduced glycated haemoglobin (HbA1c) (S/G2,−0.99% [95% CI −1.25%, −0.73%]; G1/G2, −1.11% [95% CI −1.33%, −0.89%]; G2/G2, −1.06% [95% CI −1.28%, −0.85%]). The percentage of patients achieving HbA1c < 6.5% was 27.6% in the G1/G2 group at both Week 24 and Week 52, and ranged from 27.3% to 32.7% in the G2/G2 group (difference in proportions, 5% [95% CI −6%, 17%]), while it increased from 6.8% to 27.3% from Week 24 to Week 52 in the S/G2 group (difference in proportions, 20% [95% CI 7%, 34%]). Addition of gemigliptin 50 mg qd to metformin was shown to be efficacious for 52 weeks. Switching from sitagliptin 100 mg to gemigliptin 50 mg showed consistent glyacemic control over the previous treatment.

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SN - 1462-8902

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