The FDA has approved Tradjenta (linagliptin) tablets to control blood sugar in adults with diabetes type two – to be used along with diet and exercise, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly announced today. Tradjenta can be used on its own or together with metformin, sulfonylurea or pioglitazone.
Linagliptin was shown to reduce hemoglobin A1C (HbA1C or A1C) levels up to 0.7% when compared to a placebo. A1C gives an indication on how well the diabetes patient has been able to control blood sugar during the last two to three months.
Tradjenta is not indicated for individuals with diabetic ketoacidosis or those with type 1 diabetes. The drug has not been tested in combination with insulin.
Tradjenta is a DPP-4 (dipeptidyl peptidase-4) inhibitor. Boehringer Ingelheim says it is the first type of DPP-4 inhibitor to be approved at one dosage strength – which in this case is 5mg, once a day. Those with kidney or liver impairment do not need to adjust the dosage.
Tradjenta tablets can be taken with or without food. They increase incretin levels, subsequently raising insulin levels after eating and throughout the day.
John Gerich M.D., professor of medicine, University of Rochester School of Medicine, said:
“Many people with type 2 diabetes are not able to control their blood sugar with diet and exercise alone and may also require one or more medications. The FDA approval of TRADJENTA is exciting because there is only one dose to remember for all patients, regardless of kidney or liver impairment. With TRADJENTA, physicians will have another option for managing type 2 diabetes, a potentially devastating condition.”
The FDA (Food and Drug Administration) approved Tradjenta 5mg once a day after it evaluated a clinical program consisting of approximately 4,000 adults with diabetes type 2. Placebo-controlled studies which evaluated Tradjenta on its own and along with other medications for type 2 diabetes, such as metformin, sulfonylurea or pioglitazone, were included in the program.
When used on its own (monotherapy), Tradjenta demonstrated significant A1C reductions of up to 0.7%. When taken along with metformin, sulfonylurea, and metformin plus sulfonylurea; tradjenta brought about A1C reductions of 0.6%, 0.5%, and 0.6% respectively (against a placebo).
Tradjenta was also shown to have these benefits:
- Monotherapy or in combination with metformin, sulfonylurea or pioglitazone – significant reductions in FPG (fasting plasma glucose), compared to a placebo. FPG is used to measure glucose levels after long periods without eating, such as when the patient wakes up in the morning.
- Monotherapy or in combination with metformin – significant reductions in 2-hour PPG (post-prandial glucose). PPG is used to measure the patient’s glucose levels after eating, typically two hours after food.
Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said:
“This approval provides another treatment option for the millions of Americans with Type 2 diabetes. It is effective when used alone or when added to existing treatment regimens.”
Sources: Food and Drug Administration, Eli Lilly
Written by Christian Nordvist