FDA approves Tradjenta to Treat Type 2 Diabetes

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There’s some good news for type 2 diabetes patients. Firstly it was the Gastric Bypass Surgery considered to improve insulin reaction. And now, the new drug Tradjenta is used in combination with diet and exercise to help improve blood glucose levels amongst adults in treating type 2 diabetes. It is, however, not helpful in treating type 1 diabetes.

The US Food and Drug Administration (FDA) has approved the use of Tradjenta (linagliptin) tablets for the cure of type 2 diabetes. Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, Connecticut) and Eli Lilly Co (Indianapolis, Indiana).

According to the FDA, Tradjenta is proven to be safe and helpful in type 2 diabetes patients in eight double-blind, placebo-led studies amongst 3,800 patients. These studies indicate that patients treated with Tradjenta had improved blood glucose control compared with placebo. Clinically noteworthy improvements were seen in hemoglobin A1c (A1C). HbA1c is a good estimation of how well blood sugar levels are managed.

Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research (1) asserts that the approval offers another alternative for the millions of Americans with type 2 diabetes, and is effective when used alone or when added to current treatment regimens.

The FDA said that the drug has been successfully evaluated as a separate treatment and in combination with other type 2 diabetes treatment including metformin, glimepiride and pioglitazone. Tradjenta can be taken on its own or with these other treatments, but not in company of insulin.

Tradjenta works by escalating a patient’s hormone level to stimulate the release of insulin after a meal by blocking the dipeptidyl peptidase-4 (DPP-4) enzyme.

Tradjenta should not be used in Type 1 diabetics or in those who have diabetic ketoacidosis.

Side effects

The most common side effects of the drug are upper respiratory infection. And for this reason, Tradjenta will be marketed along with a FDA Patient Package Insert specifying the drug’s benefits and also its risks.

About diabetes

Diabetes is a chronic disorder marked by high levels of glucose in the blood. Glucose is the key form of sugar in the blood, and insulin is hormones that control the amount of glucose in the blood. In diabetes, the body either cannot accurately make insulin or it cannot react to insulin. High blood glucose levels can cause many health problems and increase the threat for serious conditions including heart disease, blindness, and kidney damage.

There are two types of diabetes:

Type 1 diabetes (also called insulin-dependent diabetes) – it usually shows up in childhood and is commonly genetic. It occurs when the immune system damages insulin-producing cells in the pancreas. Patients are treated with insulin to maintain blood glucose levels within normal limits.

Type 2 diabetes (also called non-insulin-dependent diabetes) – it is the most common form of diabetes. Patients with type 2 diabetes cannot make insulin well or are not able to respond normally to insulin.

The major risk factors of type 2 diabetes include being overweight, sedentary lifestyle, and consumption of large amounts of sweet foods and junk food.

Type 2 diabetes is unquestionably the most common type of illness. Of the 25.8 million diabetics in the United States, nearly 90 percent to 95 percent have type 2 diabetes.

Sources:

Sources:
FDA’s Center for Drug Evaluation and Research