AstraZeneca Announces Phase 3 Clinical Positive Results of New Type 2 Diabetes
March 21, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];AstraZeneca today announced the positive results of Phase 3 clinical trial DERIVE, which evaluated the efficacy of FARXIGA (dapagliflozin, dapagliflozin) in patients with type 2 diabetes mellitus with moderate renal insufficiency (stage 3A chronic kidney disease) And security.
According to the US Centers for Disease Control and Prevention, there are 30.3 million people with diabetes in the United States, with type 2 diabetes accounting for 90% to 95% of all people with diabetes. In the United States, type 2 diabetes is the leading cause of chronic kidney disease, affecting more than 40% of patients.
FARXIGA is a SGLT2 inhibitor that can be used as an adjunct to diet and exercise to help control type 2 diabetes patients with blood sugar, but not for weight loss or for treating chronic kidney disease or high blood pressure.
The DERIVE trial will enroll 321 type 2 diabetes (glycated hemoglobin [HbA1c] 7-11%, mean 8.2%) and stage 3A chronic kidney disease (average estimated glomerular filtration rate [eGFR] 53 mL/min/) from 8 countries. 1.73 m2) patients were randomized to receive either 10 mg of dapagliflozin or placebo, and the study achieved primary and secondary efficacy endpoints. Studies have shown that from baseline to week 24, the 10 mg dose of dapagliflozin significantly reduced multiple markers of type 2 diabetes and chronic kidney disease, including mean HbA1c (-0.37%) (with consolation) compared with placebo. Differences - 0.34%, p < 0.001), mean body weight (-3.17 kg) (difference - 1.25 kg, p < 0.001), fasting blood glucose (-21.46 mg / dL) (difference -16.6 mg / dL, p = 0.001) Mean systolic blood pressure (-4.8 mmHg) (difference -3.1 mmHg, p <0.05) and mean eGFR (-3.23 mL/min/1.73 m2) (difference [95% CI]: -2.60 mL/min/1.73 m2 [- 5.03 vs -0.16]). Treatment-related adverse events were 10.6% and 6.2% in the dapagliflozin and placebo groups, respectively. The most common adverse events included urinary tract infections and frequent urination, with no reports of fractures or amputations. DERIVE added important information to previous studies of patients with type 2 diabetes and moderate renal impairment.
Dr. Jim McDermott, Vice President, Medical Affairs, AstraZeneca Diabetes, said: "We are committed to helping patients with complex type 2 diabetes and chronic kidney disease through a wide range of research and treatments for cardiovascular diseases, kidneys and metabolism. DERIVE Study Will help us learn more and provide more data on FARXIGA in patients with type 2 diabetes."
We expect this new drug to improve the quality of life and bring recovery to people with diabetes who have complicated chronic kidney disease.
Reference materials:
[1] AstraZeneca Shows Off New Farxiga Data for Diabetes Patients with Chronic Kidney Disease
[2] AstraZeneca Presents New Data Evaluating Safety and Efficacy of FARXIGA in Patients with Type 2 Diabetes and Moderate Renal Impairment
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