Approval was based on a phase 3 clinical trial comparing the investigative doses with the approved 1.5 mg dose.
The FDA recently approved 2 additional doses of dulaglutide (Trulicity; Eli Lilly) for the treatment of type 2 diabetes.
Approval of the 3.0 mg and 4.5 mg doses of dulaglutide was based on favorable results in regard to A1C and body weight reduction, stemming from the phase 3 AWARD-11 clinical trial comparing the additional doses with 1.5 mg doses in individuals with type 2 diabetes.
Diabetes affects an estimated 34 million Americans and approximately 463 million individuals around the world. Type 2 diabetes in particular accounts for between 90% to 95% of cases in the US.
Dulaglutide can be administered to adults with type 2 diabetes in order to improve blood sugar (glucose) as well as to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in individuals with heart disease or multiple cardiovascular risk factors.
Lilly intends to offer dulaglutide 3.0 mg and 4.5 mg by late September. "People find the Trulicity pen simple and easy-to-use," said Leonard Glass, MD, FACE, vice president of Medical Affairs, Lilly. "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."
The phase 3 randomized, double-blind, parallel arm study included 1842 participants with type 2 diabetes and sought data demonstrating not only the safety and efficacy of the 2 investigational doses of dulaglutide (3.0 mg and 4.5 mg), compared with 1.5 mg, but also that a once-weekly investigational dulaglutide dose was superior to the already approved 1.5 mg dose.
According to the study, both of the investigational doses led to significant reductions in A1C and weight in participants who remained on treatment throughout the trial:
The phase 3 trial additionally gauged change from baseline in mean body weight and fasting serum glucose, as well as percentage of patients reaching an A1C goal of less than 7% and occurrence of hypoglycemic episodes and pharmacokinetics at steady-state through 36 and 52 weeks.
"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," said Juan Pablo Frias, MD, medical director and principal investigator, National Research Institute.
"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," Frias said.