FDA Approves Additional Doses of Trulicity® (dulaglutide) for the Treatment of Type 2 Diabetes
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.
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 regarding 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.
The phase 3 randomized, double-blind, parallel arm study included 1842 participants with type 2 diabetes and sought data demonstrating the safety and efficacy of the 2 investigational doses of dulaglutide (3.0 mg and 4.5 mg) compared with 1.5 mg. In addition, the trial also wanted to establish that a once-weekly investigational dulaglutide dose was superior to the already approved 1.5 mg dose.
According to the study, both investigational doses led to significant reductions in A1c and weight in participants who remained on treatment throughout the trial:
- 4.5 mg (A1c: -1.9%; weight: -10.4 pounds)
- 3.0 mg (A1c: -1.7%; weight: -8.8 pounds)
- 1.5 mg (A1c: -1.5%; weight: -6.8 pounds)
The manufacturer of dulaglutide, Lilly, intends to have dulaglutide 3.0 mg and 4.5 mg available by late September 2020. Click here for more information.