Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after metformin failure: A randomized controlled trial
Autor: | Nayyar Iqbal, Agata Ptaszynska, Kyung-Wan Min, Ping Han, Caroline T'joen, Bei Wang, Eva Johnsson, Traci A Mansfield, Wenying Yang |
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Rok vydání: | 2016 |
Předmět: |
medicine.medical_specialty
Endocrinology Diabetes and Metabolism 030209 endocrinology & metabolism Type 2 diabetes 030204 cardiovascular system & hematology Placebo Gastroenterology law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial Weight loss law Diabetes mellitus Internal medicine medicine Dapagliflozin business.industry medicine.disease Metformin Surgery Tolerability chemistry medicine.symptom business medicine.drug |
Zdroj: | Journal of Diabetes. 8:796-808 |
ISSN: | 1753-0393 |
DOI: | 10.1111/1753-0407.12357 |
Popis: | Background Dapagliflozin, a highly selective sodium–glucose cotransporter 2 inhibitor, reduces hyperglycemia, body weight, and blood pressure in patients with type 2 diabetes (T2D). Methods This randomized double-blind placebo-controlled parallel-group 24-week study assessed the efficacy, safety, and tolerability of dapagliflozin added to metformin in Asian patients with inadequately controlled T2D (HbA1c 7.5%–10.5%). Patients were randomized to receive placebo (n = 145) or dapagliflozin 5 (n = 147) or 10 mg (n = 152). Results Most participants were Chinese (86.0%), with a mean age of 53.8 years and mean T2D duration of 4.9 years; 92.1% completed the study. Adjusted mean HbA1c changes from baseline at Week 24 (primary endpoint) were −0.23%, −0.82%, and −0.85% in the placebo, dapagliflozin 5 and 10 mg groups, respectively, resulting in dapagliflozin 5 and 10 mg versus placebo differences of −0.59% and −0.62%, respectively (both P |
Databáze: | OpenAIRE |
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