Boehringer Ingelheim and Eli Lilly and Company have received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of Jentadueto (linagliptin/metformin hydrochloride) tablets, a medicine combining the DPP-4 inhibitor, linagliptin (the active ingredient in Tradjenta tablets, marketed under the trade name Trajenta in Europe) and metformin in a single tablet taken twice daily.
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Jentadueto for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin. If approved by the European Commission, Jentadueto will provide a new, single-tablet treatment option, taken twice daily, for adults with type 2 diabetes who need to improve control of their blood glucose.
“The CHMP positive opinion for Jentadueto marks another important regulatory milestone for the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance, extending our commitment to bringing new medicines to those patients who need them,” said Prof. Klaus Dugi, corporate senior vice president Medicine, Boehringer Ingelheim. “Around the world, many people with type 2 diabetes require more than one treatment to adequately manage their blood sugar. By combining two important diabetes medicines in a single tablet, we believe that Jentadueto will provide people with type 2 diabetes another way of improving control of their blood sugar.”
Jentadueto was approved by the US Food and Drug Administration (FDA) in January 2012 as a prescription medicine used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. In clinical studies, initial combination therapy with Jentadueto was superior to metformin monotherapy and to placebo in improving haemoglobin A1c (HbA1c or A1C) and fasting plasma glucose (FPG), with a similar safety and tolerability profile. No meaningful change in body weight was noted in any treatment group.
At the maximum dose of 2.5 mg (linagliptin)/1000mg (metformin HCl) BID, Jentadueto demonstrated placebo-corrected reductions in A1C levels of up to 1.7 per cent (+0.1 per cent for placebo and -1.6 per cent for Jentadueto). A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. Jentadueto did not cause any meaningful change in body weight. Jentadueto can be used alone or in combination with a sulfonylurea, a commonly prescribed medication for type 2 diabetes. Jentadueto is not for the treatment of type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin. The Jentadueto US label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with Jentadueto.
Adverse reactions reported in greater than or equal to five percent of patients treated with Jentadueto and more commonly than in patients treated with placebo included nasopharyngitis (the common cold) and diarrhoea. Hypoglycemia was more commonly reported in patients treated with the combination of Jentadueto and sulfonylurea compared with those treated with the combination of placebo, sulfonylurea and metformin. Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person-years versus zero in 433 person-years for comparator).
Linagliptin (5 mg, once daily) is marketed as Trajenta across Europe and Canada, as Tradjenta in the US, and Trazenta in Japan, as well as in additional markets.
Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.
Jentadueto is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. It 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.
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 diarrhoea, 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.
A person has higher chance of getting lactic acidosis with Jentadueto if he 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.
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) and 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.
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. If you 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.
The most common side effects of Jentadueto include: stuffy or runny nose and sore throat and diarrhoea.
Tradjenta is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Tradjenta 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 Tradjenta is safe and effective when used with insulin.
Do not take Tradjenta if you are allergic to linagliptin or any of the ingredients in Tradjenta.
Symptoms of a serious allergic reaction to Tradjenta are rash, raised red patches on your skin (hives), 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 Tradjenta and call your doctor right away.
Tell your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin.
Tradjenta may cause serious side effects, including low blood sugar (hypoglycemia). If you take Tradjenta with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take Tradjenta.
Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.
Also tell your doctor if you take rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis.
Tradjenta may affect the way other medicines work, and other medicines may affect how Tradjenta works. Tell your doctor if you are pregnant or planning to become pregnant or are breast-feeding or plan to breast-feed. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
The most common side effects of Tradjenta include stuffy or runny nose and sore throat.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on four pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. It has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.
Lilly has been a global leader in diabetes care and works to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions—-from medicines to support programmes and more—-to make lives better.