Tianwei Gu1, Jianhua Ma2, Qiu Zhang3, Liangying Zhu1, Hong Zhang4, Lan Xu5, Jinluo Cheng6, Bimin Shi7, Dongmei Li8, Jiaqing Shao9, Zilin Sun10, Shao Zhong11, Yan Bi1, Dalong Zhu1. 1. Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China. 2. Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. 3. Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China. 4. Department of Endocrinology, Huai'an First People's Hospital, Huai'an, China. 5. Department of Endocrinology, Wuxi First People's Hospital, Wuxi, China. 6. Department of Endocrinology, Changzhou Second People's Hospital affiliated to Nanjing Medical University, Changzhou, China. 7. Department of Endocrinology, The First Affiliated Hospital of Soochow University, Suzhou, China. 8. Department of Endocrinology, Nanjing Pukou District Central Hospital, Nanjing, China. 9. Department of Endocrinology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China. 10. Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, School of Medicine, Southeast University, Nanjing, China. 11. Department of Endocrinology, Kunshan First People's Hospital, Suzhou, China.
Abstract
AIMS: To compare the efficacy and safety of saxagliptin and glimepiride in type 2 diabetes (T2D) patients who are inadequately controlled with metformin monotherapy. MATERIALS AND METHODS: In this 48-week, multi-centre, open-label, randomized, parallel trial (NCT02280486, clinicaltrials.gov), a total of 388 T2D patients were randomized 1:1 to saxagliptin or glimepiride groups. The primary endpoint was achievement of HbA1c <7.0%, without hypoglycaemia, defined as blood glucose <3.9 mmol/L and weight gain <3.0% after 48 weeks of treatment. RESULTS: Over 48 weeks, a greater proportion of patients achieved the primary endpoint with saxagliptin compared with glimepiride (43.3% vs 31.3%; odds ratio, 1.38, 95% CI, 1.05-1.82; P = 0.019), especially among patients with baseline HbA1c <8.0%, duration <5 years or baseline BMI ≥25 kg/m2 . Mean reduction in HbA1c was similar in the two treatment groups at Week 48 (-0.94% with saxagliptin vs -0.98% with glimepiride; P = 0.439). Bodyweight decreased with saxagliptin, but increased with glimepiride over the treatment period, and the treatment difference was -1.6 kg (P < 0.001) at Week 48. The proportion of patients experiencing hypoglycaemia was much lower with saxagliptin vs glimepiride (3.1% vs 12.8%; P < 0.001). CONCLUSIONS: This study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes.
RCT Entities:
AIMS: To compare the efficacy and safety of saxagliptin and glimepiride in type 2 diabetes (T2D) patients who are inadequately controlled with metformin monotherapy. MATERIALS AND METHODS: In this 48-week, multi-centre, open-label, randomized, parallel trial (NCT02280486, clinicaltrials.gov), a total of 388 T2D patients were randomized 1:1 to saxagliptin or glimepiride groups. The primary endpoint was achievement of HbA1c <7.0%, without hypoglycaemia, defined as blood glucose <3.9 mmol/L and weight gain <3.0% after 48 weeks of treatment. RESULTS: Over 48 weeks, a greater proportion of patients achieved the primary endpoint with saxagliptin compared with glimepiride (43.3% vs 31.3%; odds ratio, 1.38, 95% CI, 1.05-1.82; P = 0.019), especially among patients with baseline HbA1c <8.0%, duration <5 years or baseline BMI ≥25 kg/m2 . Mean reduction in HbA1c was similar in the two treatment groups at Week 48 (-0.94% with saxagliptin vs -0.98% with glimepiride; P = 0.439). Bodyweight decreased with saxagliptin, but increased with glimepiride over the treatment period, and the treatment difference was -1.6 kg (P < 0.001) at Week 48. The proportion of patients experiencing hypoglycaemia was much lower with saxagliptin vs glimepiride (3.1% vs 12.8%; P < 0.001). CONCLUSIONS: This study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes.
Authors: Hui Fang; Fengmei Xu; Jin Du; Li Liang; Wei Li; Liya Shen; Xueying Wang; Chun Xu; Fang Bian; Yiming Mu Journal: J Diabetes Investig Date: 2020-03-27 Impact factor: 4.232