2012年1月30日，礼来公司和勃林格殷格翰公司宣布美国食品药品管理局(FDA)已批准Jentadueto(利拉利汀/盐酸二甲双胍)用于改善成人2型糖尿病患者的血糖控制。该药适合作为饮食和运动疗法的辅助用药，用于同时适宜采用利拉利汀和二甲双胍治疗的患者。Jentadueto既可以单独用药，也可以与磺酰脲联合用药。

FDA批准利拉利汀/二甲双胍复方制剂是基于评价利拉利汀和二甲双胍作为单独片剂治疗糖尿病的临床试验结果。在最大剂量下，利拉利汀/二甲双胍组的血红蛋白A1c相对于安慰剂组的降幅达到1.7%(安慰剂组为+0.1%，利拉利汀/二甲双胍组为-1.6%)。健康受试者联合服用利拉利汀片和二甲双胍片显示与服用利拉利汀/二甲双胍复方制剂具有生物等效性。

Jentadueto治疗组中有≥ 5%的患者报告发生不良反应，该比例大于安慰剂对照组，不良反应包括鼻咽炎和腹泻。Jentadueto+磺酰脲联合治疗组与安慰剂+磺酰脲+二甲双胍联合治疗组相比，其报告发生低血糖的患者比例较高(分别为22.9% vs. 14.8%)。在这些研究中，服用利拉利汀/二甲双胍与任何明显的体重变化均无相关性。
Jentadueto的说明书中包含一个有关乳酸酸中毒的黑框警告。

Jentadueto是一种口服片剂，每日服用2次。

JENTADUETO is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. JENTADUETO can be used along with diet and exercise to help control 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). It is not known if JENTADUETO is safe and effective when used with insulin.
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 help control 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).

It is not known if JENTADUETO is safe and effective when used with insulin.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about JENTADUETO?

WARNING: RISK OF LACTIC ACIDOSIS Serious side effects can happen in people taking JENTADUETO. Metformin, one of the medicines in JENTADUETO, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking JENTADUETO and call your doctor right away if you feel very weak or tired, have unusual muscle pain, have trouble breathing, are very sleepy, have sudden nausea and vomiting or diarrhea, feel cold, especially in your arms or legs, feel dizzy or lightheaded, or have a slow or irregular heartbeat, as these could be symptoms of lactic acidosis. You have a higher chance of getting lactic acidosis with JENTADUETO if you have kidney problems, liver problems, congestive heart failure that requires medicines, drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking, get dehydrated (lose a large amount of body fluids), have certain x-ray tests with dyes or contrast agents that are injected into your body, have surgery, have a heart attack, severe infection, or stroke, and are 80 years of age or older and have not had your kidneys tested.

Who should not take JENTADUETO?
Do not take JENTADUETO if you:
have kidney problems
have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine)
are allergic to linagliptin, metformin or any of the ingredients in JENTADUETO. Symptoms of any allergic reaction are rash, raised red patches on your skin (hives), and swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking JENTADUETO and call your doctor right away
What should I tell my doctor before using JENTADUETO?
Before you take JENTADUETO, tell your doctor if you:
have kidney problems
are going to get an injection of dye or contrast agents for an x-ray procedure. JENTADUETO will need to be stopped for a short time. Talk to your doctor about when you should stop JENTADUETO and when you should start JENTADUETO again
have liver problems
have heart problems, including congestive heart failure
drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking
have any other medical conditions
are pregnant or planning to become pregnant. It is not known if JENTADUETO will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant
are breast-feeding or plan to breast-feed. It is not known if JENTADUETO passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take JENTADUETO
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JENTADUETO may affect the way other medicines work, and other medicines may affect how JENTADUETO works.

Especially tell your doctor if you take:

other medicines that can lower your blood sugar. JENTADUETO may cause serious side effects, including low blood sugar (hypoglycemia), which may become worse in people who already take another medication to treat diabetes, such as a sulfonylurea or insulin. Tell your healthcare provider if you take other diabetes medicines. Your doctor may prescribe lower doses of the sulfonylurea medicine. If you have symptoms of low blood sugar, you should check your blood sugar and treat it if it is low, then call your healthcare provider. Symptoms of low blood sugar include shaking, rapid heartbeat, hunger, headache, sweating, change in vision, and change in mood
rifampin (Rifadine®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis. Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is one that is listed above
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

What are the possible side effects of JENTADUETO tablets?
The most common side effects of JENTADUETO include:
stuffy or runny nose and sore throat
diarrhea
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.