Dosage Approved in the Summary of Product Characteristics
recommended dose of dulaglutide is 0.75 mg once weekly as
recommended dose of dulaglutide is 1.5 mg once weekly as add-on
potentially vulnerable populations 0.75 mg once weekly can be
considered as a starting dose.1
dulaglutide is added to existing metformin and/or pioglitazone
therapy, the current dose of metformin and/or pioglitazone can be
dulaglutide is added to existing metformin and/or SGLT2i therapy, the
current dose of metformin and/or SGLT2i can be continued. 1
dulaglutide is added to existing therapy of a sulphonylurea or
insulin, a reduction in the dose of sulphonylurea or insulin may be
considered to reduce the risk of hypoglycaemia.1
use of dulaglutide does not require blood glucose
self‑monitoring. Blood glucose self-monitoring is
necessary to adjust the dose of sulphonylurea or insulin,
particularly when dulaglutide therapy is started and insulin is
reduced. A stepwise approach to insulin dose reduction is
on the review by the European Medicines Agency’s CHMP, the
dulaglutide dosages listed above were approved in the Trulicity
Summary of Product Characteristics for use in the EU in 2014.1,2
CHMP noted, that when used as monotherapy or in combination with
other antihyperglycemic medications, dulaglutide administered once
weekly produced a significant and clinically relevant effect on
primary endpoint of change in glycated hemoglobin (HbA1c) from
with dulaglutide 1.5 mg once weekly was shown to be slightly more
efficacious than dulaglutide 0.75 mg once weekly. However, treatment
with dulaglutide 0.75 mg also achieved clinically relevant reductions
in HbA1c with consistent results on secondary glycemic endpoints.
Conversely, treatment with dulaglutide 0.75 mg resulted in a slightly
better tolerability and safety profile than dulaglutide 1.5 mg 2.
tolerability and safety profile of dulaglutide as monotherapy was
similar to metformin but overall more favorable with the dulaglutide
0.75 mg dose with generally less gastrointestinal effects and a lower
risk of hypoglycemia 2.
The risk-to-benefit ratio was greater at the lower dose of
dulaglutide 0.75 mg when used alone in patients who could not take
metformin or when used in elderly patients over 75 years of age.2,3
on their assessment, the CHMP concluded that
0.75 mg once weekly be approved for the monotherapy indication, and
1.5 mg once weekly be approved as add-on therapy with
dulaglutide 0.75 mg once weekly suggested as a starting
dose for add-on therapy for potentially vulnerable patients 2.
Trulicity [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Committee for Medicinal Products for Human Use (CHMP); European
Medicines Agency. Assessment report: Trulicity.
Published September 25, 2014. Accessed November 27, 2017.
European Medicines Agency. EPAR summary for the public: Trulicity.
Updated November 2014. Accessed November 27, 2017.
= Committee for Medicinal Products for Human Use
= sodium-glucose co-transporter 2 inhibitor