Efficacy and safety of alogliptin in patients with type 2 diabetes mellitus: A multicentre randomized double-blind placebo-controlled Phase 3 study in mainland China, Taiwan, and Hong Kong

Changyu Pan, Ping Han, Qiuhe Ji, Chengjiang Li, Juming Lu, Jinkui Yang, Wenhui Li, Jiaoe Zeng, An-Tsz Hsieh, Juliana Chan

Research output: Contribution to journalArticle

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Abstract

Background: This study determined the efficacy and safety of once-daily oral alogliptin in patients from mainland China, Taiwan, and Hong Kong with type 2 diabetes mellitus. Methods: In this Phase 3 multicenter double-blind placebo-controlled 16-week trial, 506 patients were randomized to receive once-daily alogliptin 25 mg or placebo: 185 in the monotherapy group, 197 in the add-on to metformin group, and 124 in the add-on to pioglitazone group. The primary efficacy variable was the change from baseline (CFB) in HbA1c at Week 16; other efficacy measures included CFB to Week 16 in fasting plasma glucose (FPG), incidence of marked hyperglycemia (FPG ≥11.1 mmol/L), and the incidence of clinical HbA1c ≤6.5 % (48 mmol/mol) and ≤7.0 % (53 mmol/mol) at Week 16. Safety was assessed throughout the trial. Results: Alogliptin monotherapy provided a significantly greater decrease in HbA1c from baseline to Week 16 compared with placebo (−0.58 %; 95 % confidence interval [CI] –0.78 %, −0.37 %; P < 0.001). As an add-on to metformin or pioglitazone, alogliptin also significantly decreased HbA1c compared with placebo (−0.69 % [95 % CI −0.87 %, −0.51 %; P < 0.001] and −0.52 % [95 % CI −0.75 %, −0.28 %; P < 0.001], respectively). In any treatment group versus placebo, alogliptin led to greater decreases in FPG (P ≤ 0.004) and a higher percentage of patients who achieved an HbA1c target of ≤6.5 % and ≤7.0 % (P ≤ 0.003). No weight gain was observed in any treatment group. A similar percentage of patients experienced drug-related, treatment-emergent adverse events in the alogliptin and placebo arms. Four and two patients in the alogliptin and placebo arms, respectively, experienced mild or moderate hypoglycemia. Conclusions: Alogliptin 25 mg once daily reduced HbA1c and FPG and enhanced clinical response compared with placebo when used as monotherapy or as an add-on to metformin or pioglitazone. Therapy with alogliptin was well tolerated.

Original languageEnglish
Pages (from-to)386-395
Number of pages10
JournalJournal of Diabetes
Volume9
Issue number4
DOIs
Publication statusPublished - Apr 1 2017

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Hong Kong
Taiwan
Type 2 Diabetes Mellitus
China
pioglitazone
Placebos
Safety
Metformin
Fasting
Glucose
Confidence Intervals
alogliptin
Incidence
Therapeutics
Hypoglycemia
Hyperglycemia
Weight Gain

Keywords

  • alogliptin
  • Asian
  • HbA1c
  • type 2 diabetes mellitus

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

Cite this

Efficacy and safety of alogliptin in patients with type 2 diabetes mellitus : A multicentre randomized double-blind placebo-controlled Phase 3 study in mainland China, Taiwan, and Hong Kong. / Pan, Changyu; Han, Ping; Ji, Qiuhe; Li, Chengjiang; Lu, Juming; Yang, Jinkui; Li, Wenhui; Zeng, Jiaoe; Hsieh, An-Tsz; Chan, Juliana.

In: Journal of Diabetes, Vol. 9, No. 4, 01.04.2017, p. 386-395.

Research output: Contribution to journalArticle

Pan, Changyu ; Han, Ping ; Ji, Qiuhe ; Li, Chengjiang ; Lu, Juming ; Yang, Jinkui ; Li, Wenhui ; Zeng, Jiaoe ; Hsieh, An-Tsz ; Chan, Juliana. / Efficacy and safety of alogliptin in patients with type 2 diabetes mellitus : A multicentre randomized double-blind placebo-controlled Phase 3 study in mainland China, Taiwan, and Hong Kong. In: Journal of Diabetes. 2017 ; Vol. 9, No. 4. pp. 386-395.
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abstract = "Background: This study determined the efficacy and safety of once-daily oral alogliptin in patients from mainland China, Taiwan, and Hong Kong with type 2 diabetes mellitus. Methods: In this Phase 3 multicenter double-blind placebo-controlled 16-week trial, 506 patients were randomized to receive once-daily alogliptin 25 mg or placebo: 185 in the monotherapy group, 197 in the add-on to metformin group, and 124 in the add-on to pioglitazone group. The primary efficacy variable was the change from baseline (CFB) in HbA1c at Week 16; other efficacy measures included CFB to Week 16 in fasting plasma glucose (FPG), incidence of marked hyperglycemia (FPG ≥11.1 mmol/L), and the incidence of clinical HbA1c ≤6.5 {\%} (48 mmol/mol) and ≤7.0 {\%} (53 mmol/mol) at Week 16. Safety was assessed throughout the trial. Results: Alogliptin monotherapy provided a significantly greater decrease in HbA1c from baseline to Week 16 compared with placebo (−0.58 {\%}; 95 {\%} confidence interval [CI] –0.78 {\%}, −0.37 {\%}; P < 0.001). As an add-on to metformin or pioglitazone, alogliptin also significantly decreased HbA1c compared with placebo (−0.69 {\%} [95 {\%} CI −0.87 {\%}, −0.51 {\%}; P < 0.001] and −0.52 {\%} [95 {\%} CI −0.75 {\%}, −0.28 {\%}; P < 0.001], respectively). In any treatment group versus placebo, alogliptin led to greater decreases in FPG (P ≤ 0.004) and a higher percentage of patients who achieved an HbA1c target of ≤6.5 {\%} and ≤7.0 {\%} (P ≤ 0.003). No weight gain was observed in any treatment group. A similar percentage of patients experienced drug-related, treatment-emergent adverse events in the alogliptin and placebo arms. Four and two patients in the alogliptin and placebo arms, respectively, experienced mild or moderate hypoglycemia. Conclusions: Alogliptin 25 mg once daily reduced HbA1c and FPG and enhanced clinical response compared with placebo when used as monotherapy or as an add-on to metformin or pioglitazone. Therapy with alogliptin was well tolerated.",
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T1 - Efficacy and safety of alogliptin in patients with type 2 diabetes mellitus

T2 - A multicentre randomized double-blind placebo-controlled Phase 3 study in mainland China, Taiwan, and Hong Kong

AU - Pan, Changyu

AU - Han, Ping

AU - Ji, Qiuhe

AU - Li, Chengjiang

AU - Lu, Juming

AU - Yang, Jinkui

AU - Li, Wenhui

AU - Zeng, Jiaoe

AU - Hsieh, An-Tsz

AU - Chan, Juliana

PY - 2017/4/1

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N2 - Background: This study determined the efficacy and safety of once-daily oral alogliptin in patients from mainland China, Taiwan, and Hong Kong with type 2 diabetes mellitus. Methods: In this Phase 3 multicenter double-blind placebo-controlled 16-week trial, 506 patients were randomized to receive once-daily alogliptin 25 mg or placebo: 185 in the monotherapy group, 197 in the add-on to metformin group, and 124 in the add-on to pioglitazone group. The primary efficacy variable was the change from baseline (CFB) in HbA1c at Week 16; other efficacy measures included CFB to Week 16 in fasting plasma glucose (FPG), incidence of marked hyperglycemia (FPG ≥11.1 mmol/L), and the incidence of clinical HbA1c ≤6.5 % (48 mmol/mol) and ≤7.0 % (53 mmol/mol) at Week 16. Safety was assessed throughout the trial. Results: Alogliptin monotherapy provided a significantly greater decrease in HbA1c from baseline to Week 16 compared with placebo (−0.58 %; 95 % confidence interval [CI] –0.78 %, −0.37 %; P < 0.001). As an add-on to metformin or pioglitazone, alogliptin also significantly decreased HbA1c compared with placebo (−0.69 % [95 % CI −0.87 %, −0.51 %; P < 0.001] and −0.52 % [95 % CI −0.75 %, −0.28 %; P < 0.001], respectively). In any treatment group versus placebo, alogliptin led to greater decreases in FPG (P ≤ 0.004) and a higher percentage of patients who achieved an HbA1c target of ≤6.5 % and ≤7.0 % (P ≤ 0.003). No weight gain was observed in any treatment group. A similar percentage of patients experienced drug-related, treatment-emergent adverse events in the alogliptin and placebo arms. Four and two patients in the alogliptin and placebo arms, respectively, experienced mild or moderate hypoglycemia. Conclusions: Alogliptin 25 mg once daily reduced HbA1c and FPG and enhanced clinical response compared with placebo when used as monotherapy or as an add-on to metformin or pioglitazone. Therapy with alogliptin was well tolerated.

AB - Background: This study determined the efficacy and safety of once-daily oral alogliptin in patients from mainland China, Taiwan, and Hong Kong with type 2 diabetes mellitus. Methods: In this Phase 3 multicenter double-blind placebo-controlled 16-week trial, 506 patients were randomized to receive once-daily alogliptin 25 mg or placebo: 185 in the monotherapy group, 197 in the add-on to metformin group, and 124 in the add-on to pioglitazone group. The primary efficacy variable was the change from baseline (CFB) in HbA1c at Week 16; other efficacy measures included CFB to Week 16 in fasting plasma glucose (FPG), incidence of marked hyperglycemia (FPG ≥11.1 mmol/L), and the incidence of clinical HbA1c ≤6.5 % (48 mmol/mol) and ≤7.0 % (53 mmol/mol) at Week 16. Safety was assessed throughout the trial. Results: Alogliptin monotherapy provided a significantly greater decrease in HbA1c from baseline to Week 16 compared with placebo (−0.58 %; 95 % confidence interval [CI] –0.78 %, −0.37 %; P < 0.001). As an add-on to metformin or pioglitazone, alogliptin also significantly decreased HbA1c compared with placebo (−0.69 % [95 % CI −0.87 %, −0.51 %; P < 0.001] and −0.52 % [95 % CI −0.75 %, −0.28 %; P < 0.001], respectively). In any treatment group versus placebo, alogliptin led to greater decreases in FPG (P ≤ 0.004) and a higher percentage of patients who achieved an HbA1c target of ≤6.5 % and ≤7.0 % (P ≤ 0.003). No weight gain was observed in any treatment group. A similar percentage of patients experienced drug-related, treatment-emergent adverse events in the alogliptin and placebo arms. Four and two patients in the alogliptin and placebo arms, respectively, experienced mild or moderate hypoglycemia. Conclusions: Alogliptin 25 mg once daily reduced HbA1c and FPG and enhanced clinical response compared with placebo when used as monotherapy or as an add-on to metformin or pioglitazone. Therapy with alogliptin was well tolerated.

KW - alogliptin

KW - Asian

KW - HbA1c

KW - type 2 diabetes mellitus

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