Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial.
Diabetes Obes Metab
; 20(3): 590-598, 2018 03.
Article
en En
| MEDLINE
| ID: mdl-28926170
ABSTRACT
AIM:
To assess the efficacy and safety of saxagliptin plus metformin over 24 weeks in pharmacotherapy-naïve Chinese patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c, 8.0%-12.0%). RESEARCH DESIGN ANDMETHODS:
In this multicentre, double-blind, active-controlled study (The START study NCT02273050, clinicaltrials.gov), patients were randomized (111) to saxagliptin 5 mg plus metformin, saxagliptin 5 mg plus placebo or metformin plus placebo. Saxagliptin was taken once daily; metformin was taken once/twice daily and was titrated from 500 mg to a maximum of 2000 mg/d over 8 weeks. The primary end point was change in HbA1c from baseline to Week 24.RESULTS:
Data from 630 patients (66.5% men; mean age, 50.1 years; mean body mass index, 26.6 kg/m2 ; mean HbA1c, 9.4%; mean diabetes duration, 0.81 years) were analysed. Mean reduction in HbA1c was greater with saxagliptin plus metformin (-3.0%) than with saxagliptin plus placebo (-2.1%; P < .001) or metformin plus placebo (-2.8%; P = .034). Changes in mean fasting plasma glucose, 120-minute postprandial glucose, and 180-minute postprandial glucose area under the curve were greater, and more patients achieved a therapeutic glycaemic response, with saxagliptin plus metformin than with either monotherapy. Hypoglycaemic events were infrequent (<2%). Incidence of adverse events was similar among groups; upper respiratory tract infection and diarrhoea were most common.CONCLUSIONS:
Saxagliptin 5 mg plus metformin significantly improved glycaemic control compared with either monotherapy in treatment-naïve Chinese patients with type 2 diabetes, and was well tolerated.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Adamantano
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Diabetes Mellitus Tipo 2
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Dipéptidos
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Hipoglucemiantes
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Metformina
Tipo de estudio:
Clinical_trials
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Prognostic_studies
Límite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Diabetes Obes Metab
Asunto de la revista:
ENDOCRINOLOGIA
/
METABOLISMO
Año:
2018
Tipo del documento:
Article
País de afiliación:
China