Saturday, 20 September 2014

FDA Approves Trulicity (dulaglutide) for Type 2 Diabetes (粮食与药物管理局批准Trulicity (dulaglutide) 为第二类型糖尿病使用)

FDA Approves Trulicity (dulaglutide) for Type 2 Diabetes (粮食与药物管理局批准Trulicity (dulaglutide) 为第二类型糖尿病使)

The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes. (美国食品药品监督管理局今天批准Trulicity (dulaglutide),每星期一次的皮下注射与饮食和锻炼一起改进糖血症控制(血糖水平),在成人与第二类型糖尿病)

Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type 2 diabetes received Trulicity. Patients receiving Trulicity had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control).

Trulicity has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. Trulicity should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); those with severe stomach or intestinal problems; or as first-line therapy for patients who cannot be managed with diet and exercise.

In clinical trials, the most common side effects observed in patients treated with Trulicity were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite. (在临床试验,在患者观察的最共同的副作用治疗与Trulicity是恶心,腹泻,呕吐,胃肠痛苦和减少的胃口。)


For further details, here is the Original Article, courtesy of FDA, USA.