The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11.
The phase 3 trial showed the additional doses led to further benefits in A1C and body weight reduction when compared to Trulicity 1.5 mg in people with type 2 diabetes.
The AWARD-11 trial evaluated the safety and efficacy of additional doses of Trulicity (3.0 mg and 4.5 mg) compared to Trulicity 1.5 mg, using two different statistical approaches.
The additional doses of Trulicity will be available in United States pharmacies in late September.
Results from AWARD-11 are also under review by the European Medicines Agency's Committee for Medicinal Products for Human Use, with an opinion on whether to recommend approval by the European Commission expected this year.
The phase 3, randomized, double-blind, parallel arm study included 1,842 participants with type 2 diabetes and evaluated the efficacy and safety of two investigational doses of dulaglutide (3.0 mg and 4.5 mg) compared to Trulicity 1.5 mg.
The primary objective of the study was to demonstrate that a once-weekly investigational dulaglutide dose (3.0 mg and/or 4.5 mg) was superior to the approved Trulicity 1.5 mg dose, as measured by A1C reduction from baseline, at 36 weeks in people with inadequately controlled type 2 diabetes on concomitant metformin therapy.
The primary and secondary objectives could be met if one or both doses achieved statistical significance for the endpoints.
Secondary and exploratory outcomes included change from baseline in mean body weight and fasting serum glucose, 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.
All participants started the study at a dose of Trulicity 0.75 mg once-weekly and then increased the dose in a step-wise approach at four week intervals to their final randomised maintenance dose of once-weekly 1.5 mg, 3.0 mg (via a 1.5 mg step) or 4.5 mg (via steps at 1.5 mg and 3.0 mg).
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