On May 2nd, 2011, the U.S. Food and Drug Administration (FDA) approved the use of Tradjenta (linagliptin) tablets for the treatment of Type 2 diabetes. Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, Connecticut) and Eli Lilly Co (Indianapolis, Indiana). Tradjenta is used in combination with diet and exercise. It improves the control of blood glucose levels in adults with Type 2 diabetes.
An estimated 25.8 million people in the United States have diabetes. In Connecticut, about 6.2% of the adult population age 18 years and older have diabetes. An additional 70,000 Connecticut adults are estimated to have undiagnosed diabetes.
Diabetes is a chronic disease characterized by high levels of glucose in the blood. Glucose is the main type of sugar in the blood. Food is broken down in the gastrointestinal tract (GI) into glucose and other nutrients needed to fuel the body. The glucose and nutrients are then absorbed into the bloodstream from the GI. This increases blood glucose levels which normally triggers the pancreas to make insulin and release it into the bloodstream. Insulin is a hormone that regulates the amount of glucose in the blood.
In diabetes, the body either cannot properly make insulin or it cannot respond to insulin. Without insulin, glucose cannot get into cells and instead stays in the bloodstream. This causes the elevated levels of glucose in the blood. High blood glucose levels can cause a lot of health problems and over time can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
There are two types of diabetes, type 1 and type 2. Blood sugar levels are higher than normal in both types, but the cause for the elevated levels is different.
- Type 1 diabetes (formerly called insulin-dependent diabetes or juvenile diabetes) occurs when the immune system destroys insulin-producing cells in the pancreas. Patients with type 1 diabetes are treated with insulin to help keep their blood glucose levels within a normal range.
- Type 2 diabetes (formerly called non-insulin-dependent diabetes) 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.
Double-blind, placebo-controlled clinical studies were performed that included 3,800 patients with Type 2 diabetes. These studies show that patients treated with Tradjenta have improved blood glucose control compared with placebo. Clinically significant improvements were seen in hemoglobin A1c (A1C). HbA1c is a good estimate of how well blood sugar levels are controlled.
Tradjenta works by blocking the enzyme dipeptidyl peptidase-4 (DPP-4). Blocking DPP-4 increases the level of hormones (incretin hormones) that stimulate the release of insulin in the body. Tradjenta should not be used in Type 1 diabetics or in those who have increased ketones in their blood or urine (diabetic ketoacidosis).
The FDA approval of Tradjenta "provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, M.D. of the FDA’s Center for Drug Evaluation and Research.
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