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DDP-4 8 articles

FDA approves Bydureon Pen for type 2 diabetes treatment

The Food and Drug Administration (FDA) has approved AstraZeneca’s Bydureon Pen, a pre-filled, single-use, pen-style delivery system for the injectable type 2 diabetes drug Bydureon. Bydureon, also known as exenatide, was approved by the FDA in 2012. It is the first and only once-weekly medicine to treat type 2 diabetes in adults. The Bydureon Pen eliminates the need for the patient to transfer the medication between a vial and syringe during the self-injection process. The pen contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide. Bydureon is in a class ... Read More

Some type 2 diabetes medications linked to increased risk of heart failure

New studies suggest two type 2 diabetes drugs do not increase the risk of heart attack, but may increase the risk of heart failure. A heart attack occurs when blood flow to part of the heart is blocked for a long enough time to cause damage or death to part of the heart muscle. Heart failure is a condition in which the heart cannot pump enough blood to the rest of the body. Both conditions can be deadly. Cardiovascular risks with diabetes medications have made headlines in recent years since the blockbuster diabetes drug Avandia was linked to fatal heart ... Read More

Januvia sales may be threatened by pancreatitis, pancreatic cancer risk

Drug maker Merck is putting most of its earnings “eggs” in one basket – Januvia, a type 2 diabetes drug – after its top-selling Singular went off patent protection and generic competition moved in. However analysts are unsure Januvia can fill the $1 billion Singular has left behind. Januvia is in a class of type 2 diabetes medications known as DPP-4 drugs. It works by inhibiting the action of the DDP-4 enzyme. It is designed to reduce blood sugar levels in patients with type 2 diabetes. The drug goes head-to-head with Onglyza, which got off to a slow start but ... Read More

Diabetes drug Tradjenta linked to acute pancreatitis, fatal pancreatitis

The safety label for the type 2 diabetes treatment Tradjenta (linagliptin) has been updated to warn that there have been reports of acute pancreatitis, including fatal pancreatitis, in patients taking the medication. Doctors and patients are advised to take special note of potential signs and symptoms of pancreatitis, and if the condition is suspected, to discontinue Tradjenta and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at an increased risk for developing the condition while using the drug. Tradjenta is an oral medication that is designed to reduce blood sugar levels in patients with ... Read More

Japan approves new type 2 diabetes treatment still under review in US

Japan’s Ministry of Health, Labour and Welfare has approved Sanofi’s Type 2 diabetes treatment Lyxumia (lixsenatide). The medication is already being sold in Mexico, the European Union, and Australia, and is currently under review in the United States. Lyxumia is the first diabetes treatment in its class in Japan. It is used in combination with basal insulin. The drug is a potent and highly selective GLP-1 peptide agonist. Other GLP-1 drugs that are marketed in the United States include Byetta and Victoza. GLP-1 is a naturally occurring peptide that is released within minutes after one eats a meal. It is ... Read More

Type 2 diabetes drug does not reduce risk of heart attack, stroke, death

Diabetes drug Onglyza (saxagliptin) does not reduce the risk of heart attacks, strokes or death from cardiovascular causes compared to a placebo, drug makers Bristol Myers Squibb and AstraZeneca said. The companies had conducted clinical trials to determine if the Type 2 diabetes treatment could help reduce the risk of non-fatal heart attacks and ischemic strokes and death from cardiovascular problems as well as lower blood glucose levels. Onglyza did not perform better than a placebo; however, it was not inferior to the placebo either. The clinical trials involved 16,500 people with diabetes as well as a history of heart ... Read More

Class of type 2 diabetes drugs linked to acute pancreatitis, pancreatic cancer, thyroid cancer

Concerns over the safety of a class of type 2 diabetes drugs known as incretin mimetics – glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors – took a sharp turn recently after an investigative report by British media revealed that it uncovered unpublished data that links the drugs to “unwanted proliferative or inflammatory pancreatic effects,” and that drug regulators in the United States and Europe have not responded quickly enough to studies that suggest these drugs are not as safe as manufacturers claim. Incretin mimetic drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, ... Read More

Newly approved type 2 diabetes drugs come with warnings, requirements

After more than five years of reviews and rejections, the dipeptidyl peptidase IV (DDP-4) inhibitor alogliptin has finally been approved by the Food and Drug Administration (FDA). The new drug was approved in three versions to improve blood sugar control in adults with type 2 diabetes. Nesina contains alogliptin as a single-agent drug; Kazano contains alogliptin with metformin; and Oseni contains alogliptin with pioglitazone. The drugs are to be prescribed in combination with diet and exercise. Alogliptin is the fourth DDP-4 inhibitor to gain FDA clearance. Others include sitagliptin, sold under the brand name Januvia; saxagliptin, sold as Onglyza; and ... Read More