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Eli Lilly introduces Trulicity, once-weekly GLP-1 RA in US markets

IndianapolisTuesday, November 11, 2014, 18:00 Hrs  [IST]

Eli Lilly and Company announced that the newest GLP-1 receptor agonist treatment option to help improve glycemic control type 2 diabetes in adults is now available in US pharmacies. Eli Lilly's Trulicity (dulaglutide) is a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) designed with patients in mind. It comes in a single-dose pen and does not require the patient to mix, measure, or handle the needle.

"Some adults with type 2 diabetes find that diet, exercise and oral medicines aren't enough to meet their treatment goals," said Dr Laura Fernandez, senior medical advisor, Lilly Diabetes. "Trulicity may be an option for them as it has demonstrated proven glycemic control, only has to be taken once weekly, and comes in an easy-to-use pen."

Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease.

Trulicity has a Boxed Warning about potential risk of thyroid c-cell tumors including medullary thyroid carcinoma (MTC). It is contraindicated in patients with a personal history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of its product components.

The US Food and Drug Administration approved Trulicity on September 18, 2014 based on results from a number of studies of Trulicity used alone or in combination with commonly prescribed diabetes medications, including metformin, pioglitazone, glimepiride, and insulin lispro. (Study details are available below.) It is now available to patients in 0.75 mg and 1.5 mg doses, delivered in the single-dose Trulicity pen. In a separate usability study, most patients agreed the Trulicity pen was easy to use.

To help make the cost of therapy more manageable, the Trulicity Savings Card can reduce out-of-pocket costs to $25 for each prescription of Trulicity (up to a value of $150 per month) for a maximum of two years. This is available for commercially insured patients only.

Trulicity is a once-weekly, glucagon-like peptide-1 receptor agonist (GLP-1 RA) injectable prescription medicine indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not insulin. It acts like GLP-1, a natural hormone, helping the body release its own insulin when patients eat to control blood sugar.

Trulicity comes in a pen and does not require the patient to mix, measure, or handle the needle. It can be taken any time of day, with or without meals, and should be injected subcutaneously in the abdomen, thigh, or upper arm.

Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease.

People with type 2 diabetes, caregivers of people with diabetes, and healthcare professionals who treat diabetes participated in a study on the safe and effective use of the Trulicity pen and the instructions for the Trulicity pen. One hundred twenty-eight people completed a questionnaire on their experiences using the pen and the instructions. One question in the questionnaire asked for users' responses to, "overall easy to use the medication delivery device."


Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world.

 
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