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.

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.

• Authors: Changyu Pan, Ping Han, Qiuhe Ji, Chengjiang Li, Juming Lu, Jinkui Yang, Wenhui Li, Jiaoe Zeng, An-Tsz Hsieh, Juliana Chan
• Journal: Journal of diabetes (J Diabetes) Vol. 9 Issue 4 Pg. 386-395 (Apr 2017) ISSN: 1753-0407 [Electronic] Australia
• PMID: 27171508 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2016 The Authors. Journal of Diabetes published by John Wiley & Sons Australia, Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.

Chemical References

• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Piperidines
• Thiazolidinediones
• Uracil
• Metformin
• alogliptin
• Pioglitazone

Topics

• Adult
• Aged
• Asian People
• Blood Glucose (metabolism)
• China
• Diabetes Mellitus, Type 2 (blood, drug therapy, ethnology)
• Double-Blind Method
• Drug Therapy, Combination
• Fasting (blood)
• Female
• Glycated Hemoglobin (metabolism)
• Hong Kong
• Humans
• Hypoglycemic Agents (therapeutic use)
• Male
• Metformin (therapeutic use)
• Middle Aged
• Pioglitazone
• Piperidines (therapeutic use)
• Taiwan
• Thiazolidinediones (therapeutic use)
• Treatment Outcome
• Uracil (analogs & derivatives, therapeutic use)