The US Food and Drug Administration (FDA) included the changes to the approved product labeling to reflect this important information for prescribers. Trulicity is available in a prefilled pen in 0.75 and 1.5mg doses.
Lilly Diabetes global medical affairs vice president Sherry Martin, M.D. said: "Despite best efforts to manage their A1C, many adults with type 2 diabetes may need to add to or change their treatment plan to help them reach their blood sugar goals.
"They now have the option to use Trulicity, with its powerful efficacy in a once-weekly, easy-to-use pen, along with basal insulin for even greater control."
Trulicity is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes. It should be used along with diet and exercise.
Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas (pancreatitis). It is not a substitute for insulin. Trulicity should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe stomach or intestinal problems. It has not been studied in children under 18 years of age.
Trulicity has a Boxed Warning about potential thyroid tumors, including cancer. It should not be taken by someone with a personal or family history of medullary thyroid cancer, a personal history of Multiple Endocrine Neoplasia syndrome type 2, or an allergy to Trulicity.
The Trulicity label update is based on FDA review of results from the AWARD-9 clinical trial, a Phase 3b, randomized, double-blind, placebo-controlled, 28-week study that evaluated the efficacy and safety of once-weekly Trulicity 1.5mg as an add-on to titrated insulin glargine, with or without metformin, compared to placebo as an add-on to titrated insulin glargine, with or without metformin.
Study results showed that Trulicity 1.5mg significantly reduced A1C as an add-on to insulin glargine (1.4 percent) after 28 weeks compared to placebo plus insulin glargine (0.7 percent).
The label was also updated to include results from the AWARD-8 clinical trial, a Phase 3b randomized, double-blind, placebo-controlled, 24-week study that evaluated the efficacy and safety of Trulicity 1.5mg as an add-on to sulfonylurea compared to placebo plus sulfonylurea.
Trulicity was first approved in September 2014 as a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes, based in part on results from five Phase 3 studies of Trulicity used alone or in combination with other diabetes medications, including metformin, pioglitazone, glimepiride and insulin lispro.
With this update, Trulicity is the first and only GLP-1 receptor agonist with a label that allows its use in combination with mealtime insulin or basal insulin.