2014年8月5日訊 /生物谷BIOON/ --勃林格殷格翰-禮來糖尿病聯盟8月4日宣布，糖尿病藥物Jentadueto片（利拉利汀/鹽酸二甲雙胍）美國處方信息更新，納入了一項為期24周的IV期臨床數據：與利拉利汀（linagliptin）單藥相比，利拉利汀+二甲雙胍複方療法使高基線A1C水平（糖化血紅蛋白）初治2型糖尿病成人患者的血糖水平取得了統計學意義的顯著下降。
該IV期臨床試驗是一項24周、隨機、雙盲研究，在高基線A1C水平（8.5%≤A1C≤12.0%）的初治2型糖尿病成人患者中開展，評價了利拉利汀（5mg/天）+二甲雙胍（1500-2000mg/天）複方療法（n=159）相對於利拉利汀（5mg/天）單藥療法（n=157）的療效和安全性。研究的主要終點是，經過24周治療後A1C水平從基線的變化。數據表明，利拉利汀+二甲雙胍複方組A1C水平從基線下降2.9%，利拉利汀單藥組A1C水平從基線下降2.0%，數據具有統計學顯著差異。關鍵次要終點方面，與利拉利汀單藥組相比，利拉利汀+二甲雙胍複方組空腹血糖（FPG）取得了統計學意義的顯著下降（FPG：54mg/L vs 35mg/L），複方組有更多的患者實現A1C≤7的目標（54% vs 30%）；研究者定義的低血糖事件在2個治療組相似（複方組1.9%，單藥組3.2%）。
該項研究中，初治成人患者的定義為，在進入隨機化治療前的12周，患者未接受任何降糖療法。
利拉利汀（linagliptin）在美國的品牌名為Tradjenta，該藥為每日一次的5mg片劑，結合飲食和運動，用於改善2型糖尿病（T2D）患者的血糖控制。該藥不適用於1型糖尿病及糖尿病酮症酸中毒的治療。
利拉利汀/鹽酸二甲雙胍複方藥的品牌名為Jentadueto，該藥是一種處方藥，於2012年1月獲FDA批准，適用於適合利拉利汀和二甲雙胍治療的2型糖尿病患者。Jentadueto不適用於1型糖尿病及糖尿病酮症酸中毒的治療。Jentadueto的標籤附有一個黑框警告，指示乳酸性酸中毒風險。（生物谷Bioon.com）
英文原文：Type 2 diabetes: Jentadueto® (linagliptin and metformin hydrochloride) tablets label updated to include new data on blood glucose reductions in treatment-naive adults with high baseline A1C
- Combination of linagliptin and metformin significantly reduced blood glucose levels compared with linagliptin alone
RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 4, 2014 /PRNewswire/ -- The U.S. Prescribing Information for Jentadueto® (linagliptin and metformin hydrochloride) tablets now includes clinical trial data that showed linagliptin co-administered with metformin provided statistically significant decreases in blood glucose compared with linagliptin alone in treatment-naive* adults with type 2 diabetes and high baseline A1C levels (A1C of > /=8.5 to < /=12.0 percent). Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) announced today that the data, based on results from a prospective 24-week phase IV clinical trial, have been added to the "Clinical Studies" section of the JENTADUETO U.S. Prescribing Information.
"We are extremely pleased with the addition to the JENTADUETO label. These data support the use of JENTADUETO as an initial type 2 diabetes treatment option in an important patient population - treatment-naive adults who have high baseline A1C levels," said Christophe Arbet-Engels, M.D., Ph.D., vice president, metabolic clinical development and medical affairs, BIPI. "In addition, these data reinforce the use of JENTADUETO, as an adjunct to diet and exercise, in helping adults with type 2 diabetes improve glycemic control."
The 24-week, randomized, double-blind study assessed the efficacy and safety of linagliptin (5 mg per day) in combination with metformin (1500 to 2000 mg per day; n=159) vs. linagliptin (5 mg per day; n=157) alone in treatment-naive adults with type 2 diabetes and high baseline A1C (A1C of > /=8.5 to < /=12.0 percent).
The primary endpoint of the trial — change from baseline in A1C after 24 weeks — demonstrated that initial therapy with the combination of linagliptin and metformin reduced A1C levels from baseline by 2.9 percent compared with 2.0 percent for linagliptin alone. There was a statistically significant mean difference in A1C between the combination and linagliptin alone of -0.84 percent. Key secondary findings showed fasting plasma glucose (FPG) levels were significantly decreased with the combination treatment compared with linagliptin alone (54 mg/dL vs. 35 mg/dL, mean difference -18 mg/dL) and that a greater percentage of patients achieved an A1C less than 7 percent with the combination of linagliptin and metformin (54 percent) compared with linagliptin alone (30 percent). The percentage of patients with investigator-defined hypoglycemic events was similar between treatment arms (linagliptin and metformin, 1.9 percent; linagliptin, 3.2 percent).
*note: Treatment-naive adults in this study were defined as adults with no antidiabetic therapy for 12 weeks prior to randomization.
Please see full Prescribing Information for JENTADUETO, including Boxed Warning regarding the risk of lactic acidosis, and Medication Guide.
About Linagliptin
Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRADJENTA has not been studied in patients with a history of pancreatitis.
About Linagliptin/Metformin Hydrochloride
Linagliptin/metformin hydrochloride, which is marketed as Jentadueto® (linagliptin and metformin hydrochloride) tablets in the U.S., is a prescription medicine that contains two diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to improve glycemic control in adults with T2D when treatment with both linagliptin and metformin is appropriate. JENTADUETO should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JENTADUETO has not been studied in patients with a history of pancreatitis. The JENTADUETO label contains a Boxed Warning for the risk of lactic acidosis, a rare, but serious, complication that can occur due to metformin accumulation during treatment with JENTADUETO.
JENTADUETO was approved based on clinical trials that evaluated linagliptin and metformin as separate tablets. Bioequivalence of JENTADUETO was demonstrated with co-administered linagliptin and metformin tablets in healthy subjects.
What is JENTADUETO?
JENTADUETO is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.
JENTADUETO is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).