Efficacy and safety of trelagliptin in combination with insulin therapy in Japanese patients with type 2 diabetes: Results from a randomized, Phase IV study.
Diabetes Obes Metab
; 20(10): 2490-2493, 2018 10.
Article
em En
| MEDLINE
| ID: mdl-29862617
ABSTRACT
We aimed to explore the efficacy and safety of once-weekly trelagliptin 100 mg as an add-on therapy to insulin in Japanese patients with type 2 diabetes mellitus with inadequate glycaemic control. Patients with haemoglobin A1c (HbA1c) 7.5% to 10.0% who were receiving 8 to 40 units of insulin per day were randomized to receive, with insulin, trelagliptin 100 mg (A/A, n = 116) or placebo (P/A, n = 124) for a 12-week double-blind (DB) phase, after which all received trelagliptin for a 40-week open-label phase. Primary endpoints were HbA1c change from baseline to the end of the DB phase and adverse events (AEs). HbA1c significantly decreased in the A/A group vs the P/A group at the end of the DB phase (least square mean difference, -0.63% [95% CI, -0.83 to -0.44] P < .0001). The frequency of treatment-emergent AEs during the DB phase was 44.0% in the A/A group and 47.6% in the P/A group. No patient experienced severe hypoglycaemia during trelagliptin treatment. Once-weekly trelagliptin 100 mg therapy with insulin demonstrated a significant reduction in HbA1c. Long-term treatment was well-tolerated, with no clinically significant hypoglycaemia, suggesting that trelagliptin with insulin is a meaningful treatment option in this patient population.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Uracila
/
Diabetes Mellitus Tipo 2
/
Insulina
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Aged
/
Female
/
Humans
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Male
/
Middle aged
País/Região como assunto:
Asia
Idioma:
En
Revista:
Diabetes Obes Metab
Assunto da revista:
ENDOCRINOLOGIA
/
METABOLISMO
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Japão