New Phase 3 data for Tradjenta® (linagliptin) tablets in black or African American patients with type 2 diabetes showed significant improvement in blood sugar
TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. TRADJENTA is a DPP-4 inhibitor that does not require dose adjustments regardless of declining renal function or hepatic impairment.[2] TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.
In the U.S., African Americans and other ethnic minorities are significantly underrepresented in clinical trials.[3] This is the first published trial of a DPP-4 inhibitor specifically conducted in black or African American adult patients with type 2 diabetes.
"These findings support the efficacy and safety profile of linagliptin as a treatment option for African American adult patients with type 2 diabetes," said lead investigator
African American adults are disproportionately affected by diagnosed diabetes. In the U.S., the risk of diabetes is 77 percent greater for non-Hispanic black adults, when compared to non-Hispanic white adults,[4] with an estimated 18.7 percent (4.9 million) of all non-Hispanic black adults living with the disease.[4]
In the 24-week study, 226 patients were randomized (106 to linagliptin, and 120 to placebo)[1], and received at least one dose of the study drug in order to be included in the safety analyses.[1] Patients who had a measurement of A1C at baseline (linagliptin 8.63 percent +/-0.11; placebo 8.70 percent +/-0.11) and at least one measurement post-baseline (200) were included in the analyses of efficacy.[1] A1C was measured every six weeks during the study and the difference between the groups was significantly different by six weeks and remained so throughout the study.[1]
The number of patients experiencing adverse events was similar for the linagliptin and placebo groups.[1] The most common adverse events reported in this trial were hyperglycemia (high blood sugar levels [linagliptin 2.8 percent; placebo 9.2 percent]) and nasopharyngitis (inflammation of the nose or pharynx [linagliptin 3.8 percent; placebo 5 percent]).[1] Hypoglycemia occurred in three patients in the linagliptin group and one patient in the placebo group, and none of the events required external assistance.[1]
"These data are important because we know that African Americans are significantly more likely to have diabetes than non-Hispanic Whites," said
A secondary endpoint of the study looked at the proportion of patients with an A1C value of less than 7.0 percent,[1] a target level recommended by the
Patients in the linagliptin group were also significantly more likely to see an A1C reduction of at least half a percent at week 24, with more than half the patients (55.3 percent) in the linagliptin group having a reduction of 0.5 percent or more, compared with 28.3 percent in the placebo group (p < 0.0001).[1]
To learn more about linagliptin and for full prescribing information visit: www.TRADJENTA.com, or call
What are TRADJENTA tablets?
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.
Important Safety Information
Who should not take TRADJENTA?
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.
What should I tell my doctor before taking TRADJENTA?
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.
What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-
For more safety information, please see Patient Information and full Prescribing Information.
To learn more about TRADJENTA visit: www.TRADJENTA.com. For full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf or call
Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.
About Diabetes
Approximately 25.8 million Americans[4] and an estimated 366 million people worldwide[6] have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.[4]Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.[7]
Boehringer Ingelheim and
In
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim,
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2011, Boehringer Ingelheim achieved net sales of about
For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus .
About
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. Headquartered in
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we work 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 programs and more—-to make lives better.
For more information, visit www.lillydiabetes.com.
This press release contains forward-looking statements about TRADJENTA for the treatment of type 2 diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that TRADJENTA will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the
P-LLY
TJ224100
(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )
(Logo: http://photos.prnewswire.com/prnh/20110825/DE57898LOGO )
[1] Thrasher et al. Study of Linagliptin in African American patients with Type 2 Diabetes. Presented at
[2] Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011.
[3]Increasing Minority Population in Clinical Research.
[4]
[5]
[6]
[7]
SOURCE
News Provided by Acquire Media