Jingtao Dou1, Jianhua Ma2, Jun Liu3, Changjiang Wang4, Eva Johnsson5, Hui Yao6, June Zhao7, Changyu Pan1. 1. Department of Endocrinology, The General Hospital of People's Liberation Army, Beijing, China. 2. Department of Endocrinology, Nanjing First Hospital, Nanjing, China. 3. Department of Endocrinology, The Fifth People's Hospital of Shanghai, Fudan University, Shanghai, China. 4. Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China. 5. Global Medicines Development, AstraZeneca, Gothenburg, Mölndal, Sweden. 6. China Development Unit, AstraZeneca, Shanghai, China. 7. AstraZeneca, Gaithersburg, Maryland.
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 AND METHODS: In this multicentre, double-blind, active-controlled study (The START study: NCT02273050, clinicaltrials.gov), patients were randomized (1:1:1) 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.
RCT Entities:
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 AND METHODS: In this multicentre, double-blind, active-controlled study (The START study: NCT02273050, clinicaltrials.gov), patients were randomized (1:1:1) 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.
Authors: Sushrima Gan; Adem Y Dawed; Louise A Donnelly; Anand T N Nair; Colin N A Palmer; Viswanathan Mohan; Ewan R Pearson Journal: Diabetes Care Date: 2020-08 Impact factor: 19.112
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Authors: Linong Ji; Juliana C N Chan; Miao Yu; Kun Ho Yoon; Sin Gon Kim; Sung Hee Choi; Chien-Ning Huang; Shih Te Tu; Chih-Yuan Wang; Päivi Maria Paldánius; Wayne H H Sheu Journal: Diabetes Obes Metab Date: 2020-11-09 Impact factor: 6.577