AWARD-11 showed 3.0 mg and 4.5 mg doses led to additional blood sugar control; as a secondary endpoint, both doses also led to weight loss
Eli Lilly Corporate Center, Indianapolis, Indiana, US. (Credit: Momoneymoproblemz/Wikipedia.)
Eli Lilly and Company (Lilly) has secured the expanded US Food and Drug Administration (FDA) approval for two additional doses, 3mg and 4.5mg, of Trulicity (dulaglutide) to treat type 2 diabetes.
Trulicity is a weekly once prescription medicine intended for treating type 2 diabetes by improving blood sugar and reducing the risk of major cardiovascular events, including death, heart attack, or stroke in people with heart disease or several cardiovascular risk factors.
The US regulatory approval for new dosages was based on data from Phase 3 AWARD-11 trial, which evaluated the safety and efficacy of additional doses of Trulicity compared to the 1.5 mg dose of the drug, using two different statistical approaches, said the company.
National Research Institute medical director and principal investigator Juan Pablo Frias said: “The FDA’s decision to approve the additional doses of Trulicity is a positive step forward for people living with type 2 diabetes and their care teams.
“This progressive condition can require different treatment approaches over time, and findings from AWARD-11 showed the additional doses of Trulicity can lead to further A1C and weight reductions for people with type 2 diabetes whose current treatment may no longer be meeting their needs.”
AWARD-11 trial evaluated the efficacy and safety of additional Trulicity doses
AWARD-11 is a Phase 3, randomised, double-blind, parallel-arm clinical trial that evaluated the efficacy and safety of two investigational doses of the drug in 1,842 type 2 diabetes patients.
The primary objective of the study includes establishing the superiority of the new 3mg and 4.5mg doses of the drug, to the approved 1.5mg dose, in people with uncontrolled type 2 diabetes, on concomitant metformin therapy.
Secondary and exploratory outcomes include the change from baseline in mean body weight and fasting serum glucose (FSG), percentage age of patients reaching an A1C goal of less than 7% and occurrence of hypoglycemic episodes and pharmacokinetics at steady-state.
Participants are initially given a dose of Trulicity 0.75mg once-weekly, with an increase in dose at four-week intervals to the final randomised maintenance dose of once-weekly 1.5mg, 3mg or 4.5mg.
In the Phase 3 trial, the additional doses showed further benefits in A1C and body weight reduction compared to Trulicity 1.5mg in people with type 2 diabetes.
Results from AWARD-11 are also being reviewed by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use, with European Commission (EC)’s opinion to recommend approval expected in this year.
Lilly medical affairs vice president Leonard Glass said: “People find the Trulicity pen simple and easy-to-use. Now, with the 3.0 and 4.5 doses available, people with type 2 diabetes who use Trulicity can benefit from additional A1C and weight loss as their condition progresses.”