Efficacy and safety of cetagliptin as monotherapy in patients with type 2 diabetes : A randomized, double-blind, placebo-controlled phase 3 trial
© 2023 John Wiley & Sons Ltd..
AIM: To assess the efficacy and safety of the dipeptidyl peptidase-4 inhibitor, cetagliptin, as monotherapy in Chinese patients with type 2 diabetes (T2D) and inadequate glycaemic control.
MATERIALS AND METHODS: In total, 504 eligible patients with T2D were enrolled and randomized to cetagliptin 50 mg once daily, cetagliptin 100 mg once daily or placebo at a ratio of 2:2:1 for 24 weeks of double-blind treatment, then all patients received cetagliptin 100 mg once daily for 28 weeks of open-label treatment. The primary efficacy endpoint was the change in HbA1c level from baseline at week 24.
RESULTS: After 24 weeks, HbA1c from baseline was significantly reduced with cetagliptin 50 mg (-1.08%) and cetagliptin 100 mg (-1.07%) compared with placebo (-0.35%). The placebo-subtracted HbA1c reduction was -0.72% with cetagliptin 50 mg and 100 mg. Patients with a baseline HbA1c of 8.5% or higher had a greater HbA1c reduction with cetagliptin than those patients with a baseline HbA1c of less than 8.5%. Both doses studied led to a significantly higher proportion of patients (42.3% with 100 mg and 45.0% with 50 mg) achieving an HbA1c of less than 7.0% compared with placebo (12.9%). Cetagliptin also significantly lowered fasting plasma glucose and 2-hour postmeal plasma glucose relative to placebo. The incidence of adverse experiences was similar between cetagliptin and placebo. No drug-related hypoglycaemia was reported.
CONCLUSIONS: Cetagliptin monotherapy was effective and well tolerated in Chinese patients with T2D who had inadequate glycaemic control on exercise and diet.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:25 |
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| Enthalten in: |
Diabetes, obesity & metabolism - 25(2023), 12 vom: 01. Dez., Seite 3671-3681 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ji, Linong [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 13.11.2023 Date Revised 13.11.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/dom.15261 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Ji, Linong |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of cetagliptin as monotherapy in patients with type 2 diabetes |b A randomized, double-blind, placebo-controlled phase 3 trial |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Revised 13.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 John Wiley & Sons Ltd. | ||
| 520 | |a AIM: To assess the efficacy and safety of the dipeptidyl peptidase-4 inhibitor, cetagliptin, as monotherapy in Chinese patients with type 2 diabetes (T2D) and inadequate glycaemic control | ||
| 520 | |a MATERIALS AND METHODS: In total, 504 eligible patients with T2D were enrolled and randomized to cetagliptin 50 mg once daily, cetagliptin 100 mg once daily or placebo at a ratio of 2:2:1 for 24 weeks of double-blind treatment, then all patients received cetagliptin 100 mg once daily for 28 weeks of open-label treatment. The primary efficacy endpoint was the change in HbA1c level from baseline at week 24 | ||
| 520 | |a RESULTS: After 24 weeks, HbA1c from baseline was significantly reduced with cetagliptin 50 mg (-1.08%) and cetagliptin 100 mg (-1.07%) compared with placebo (-0.35%). The placebo-subtracted HbA1c reduction was -0.72% with cetagliptin 50 mg and 100 mg. Patients with a baseline HbA1c of 8.5% or higher had a greater HbA1c reduction with cetagliptin than those patients with a baseline HbA1c of less than 8.5%. Both doses studied led to a significantly higher proportion of patients (42.3% with 100 mg and 45.0% with 50 mg) achieving an HbA1c of less than 7.0% compared with placebo (12.9%). Cetagliptin also significantly lowered fasting plasma glucose and 2-hour postmeal plasma glucose relative to placebo. The incidence of adverse experiences was similar between cetagliptin and placebo. No drug-related hypoglycaemia was reported | ||
| 520 | |a CONCLUSIONS: Cetagliptin monotherapy was effective and well tolerated in Chinese patients with T2D who had inadequate glycaemic control on exercise and diet | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a DPP-4 | |
| 650 | 4 | |a T2D | |
| 650 | 4 | |a cetagliptin | |
| 650 | 4 | |a dipeptidyl peptidase-4 inhibitor | |
| 650 | 4 | |a type 2 diabetes | |
| 650 | 7 | |a Blood Glucose |2 NLM | |
| 650 | 7 | |a Glycated Hemoglobin |2 NLM | |
| 650 | 7 | |a Hypoglycemic Agents |2 NLM | |
| 700 | 1 | |a Lu, Jinmiao |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Leili |e verfasserin |4 aut | |
| 700 | 1 | |a Ying, Changjiang |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Jiao |e verfasserin |4 aut | |
| 700 | 1 | |a Han, Jie |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Wenhua |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Yunming |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Kun |e verfasserin |4 aut | |
| 700 | 1 | |a Zheng, Xin |e verfasserin |4 aut | |
| 700 | 1 | |a Xie, Daosheng |e verfasserin |4 aut | |
| 700 | 1 | |a Ding, Juping |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Jiahong |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Qiang |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Tong |e verfasserin |4 aut | |
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