Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase.
Expert Opin Pharmacother
; 15(15): 2121-30, 2014 Oct.
Article
em En
| MEDLINE
| ID: mdl-25190226
ABSTRACT
OBJECTIVE:
To evaluate the efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes mellitus (T2DM) who are poorly controlled with insulin and diet or exercise. STUDYDESIGN:
This was a randomized, double-blind, 12-week comparative trial of alogliptin and insulin versus placebo and insulin in 179 patients with T2DM followed by a 40-week, open-label phase in 169 patients on alogliptin and insulin. PRIMARY OUTCOMEMEASURE:
Change in glycated hemoglobin (HbA1c) from baseline to the end of double-blind phase (week 12).RESULTS:
The change in HbA1c (least squares means) from baseline to week 12 was -0.96% for the alogliptin and insulin group and -0.29% for the placebo and insulin group. The point estimate (95% confidence interval) intergroup difference was -0.66% ([-0.824%, -0.503%]). In the alogliptin and insulin group, HbA1c started to decrease from week 2 onward and peaked by week 12. The proportions of patients who achieved HbA1c < 8.0, < 7.0 and < 6.0% at week 12 were significantly higher in alogliptin and insulin group (73.0, 23.3 and 1.1%) than in placebo and insulin group (25.0, 5.7 and 0%). Incidences of adverse effects were comparable between groups, with no relevant increases in hypoglycemia or weight gain seen.CONCLUSIONS:
Alogliptin 25 mg/day was effective and well tolerated when added to insulin in Japanese patients with inadequately controlled T2DM.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Piperidinas
/
Uracila
/
Diabetes Mellitus Tipo 2
/
Hipoglicemiantes
/
Insulina
Tipo de estudo:
Clinical_trials
Limite:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
Expert Opin Pharmacother
Assunto da revista:
FARMACOLOGIA
Ano de publicação:
2014
Tipo de documento:
Article