A Phase IV Study in Drug-Naive Patients With T2DM in China

Summary

This is a 24-week, multicenter, randomized, open-label, parallel-group, active controlled Phase IV study to assess the efficacy and safety of Dapagliflozin as monotherapy compared with Acarbose in patients with T2DM who were inadequately controlled with diet and exercise. The study is designed to evaluate the efficacy and safety of dapagliflozin monotherapy compared with acarbose monotherapy in patients with T2DM inadequately controlled with diet and exercise.

Timeline

Start

2017-12-15

Primary completion

2019-05-24

Completion

2019-05-24

Publications

• Background 1. Cefalu, W.T., et al., Dapagliflozin's Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes: A 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a 28-Week Extension. Diabetes Care, 2015. 38(7): p. 1218-27. 2. Yang, W., et al., Prevalence of diabetes among men and women in China. N Engl J Med, 2010. 362(12): p. 1090-101. 3. Ji, L., et al., Primacy of the 3B approach to control risk factors for cardiovascular disease in type 2 diabetes patients. Am J Med, 2013. 126(10): p. 925.e11-22. 4. 中华医学会糖尿病学分会, 中国2型糖尿病防治指南(2013年版). 中华糖尿病杂志, 2014. 06((07): p. 447-498. 5. Komoroski, B., et al., Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther, 2009. 85(5): p. 513-9. 6. Henry, R.R., et al., Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract, 2012. 66(5): p. 446-56. 7. Nauck, M.A., et al., Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care, 2011. 34(9): p. 2015-22. 8. 中华医学会糖尿病分会, 中国2型糖尿病防治指南2013年版. 9. Johnsson, K.M., et al., Urinary tract infections in patients with diabetes treated with dapagliflozin. J Diabetes Complications, 2013. 27(5): p. 473-8. 10. Johnsson, K.M., et al., Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complications, 2013. 27(5): p. 479-84.

Drugs

Indications