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FDA Approves Trulicity® Once Weekly Use In Combo With Daily Basal and Rapid Insulins

Only GLP-1 receptor agonist for use with mealtime or basal insulin for adults with type 2

The FDA has updated the label for once-weekly dulaglutide (Trulicity, Eli Lilly), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, to include use in combination with basal insulin in adults with type 2 diabetes. Dulaglutide is available in a prefilled pen in 0.75-mg and 1.5-mg doses. The update makes dulaglutide (Trulicity), the first GLP-1 receptor agonist with a label indication for combination use with mealtime or basal insulin.

It is getting more difficult to treat patients with the most effective therapy when we have all these possible combinations.  Right now it is trial and error to find the best treatment, but coming soon is a software program that will be able to determine with a blood test that focuses on your genes what the best treatment will be for each patient.

Despite best efforts to manage their HbA1c, many adults with type 2 diabetes may need to add to or change their treatment plan to help them reach their blood sugar goals.  So, now they have the option to use Trulicity, with its powerful efficacy in a once-weekly, easy-to-use pen, along with basal of rapid-acting insulin for better control.

The label update was based on an FDA review of results from the AWARD-9 trial, a phase 3b, randomized, double-blind, placebo-controlled, 28-week study that evaluated the efficacy and safety of once-weekly dulaglutide 1.5 mg as an add-on to titrated insulin glargine, with or without metformin, compared with placebo as an add-on to titrated insulin glargine, with or without metformin. In the study, dulaglutide 1.5 mg significantly reduced hemoglobin A1c as an add-on to insulin glargine after 28 weeks compared with placebo plus insulin glargine (1.4% vs. 0.7%, respectively).

The label update also include results from the AWARD-8 trial, a phase 3b randomized, double-blind, placebo-controlled, 24-week study that evaluated the efficacy and safety of dulaglutide 1.5 mg as an add-on to sulfonylurea compared with placebo plus sulfonylurea.

Dulaglutide was approved in September 2014 as a once-weekly injectable prescription medication to improve glucose levels in adults with type 2 diabetes, based partly on results from five phase-3 studies of dulaglutide used alone or in combination with other diabetes medications, including metformin, pioglitazone, glimepiride, and insulin lispro. With the new update, dulaglutide is the only GLP-1 receptor agonist with a label that allows its use in combination with mealtime insulin or basal insulin.

Dulaglutide is not recommended as the first medication to treat diabetes. It has not been studied in people who have had pancreatitis. Dulaglutide should not be used by people with type 1 diabetes, by people with diabetic ketoacidosis, or by people with a history of severe stomach or intestinal problems. It has not been studied in children younger than 18 years of age.

The dulaglutide label includes a boxed warning regarding potential thyroid tumors, including cancer. The medication should not be taken by someone with a personal or family history of medullary thyroid cancer.

Practice Pearls:

  • Trulicity is the first GLP-1 receptor agonist with a label that allows its use in combination with mealtime insulin or basal insulin.
  • The product is available in a prefilled pen in 0.75 and 1.5 mg doses.
  • Study results showed that Trulicity 1.5 mg significantly reduced A1C as an add-on to insulin glargine (1.4 percent) after 28 weeks.