Dulaglutide

Type 2 Diabetes Mellitus Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes.

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TRULICITY (dulaglutide) is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with: • diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance.

• metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control. • metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control.

• sodium glucose co-transporter 2 inhibitor (SGLT2i) with metformin, when diet and exercise plus SGLT2i with or without metformin do not achieve adequate glycemic control. • basal insulin with metformin, when diet and exercise plus basal insulin with or without metformin do not achieve adequate glycemic control.

• prandial insulin with metformin, when diet and exercise plus basal or basal-bolus insulin therapy (up to two injections of basal or basal plus prandial insulin per day) with or without oral antihyperglycemic medications, do not achieve adequate glycemic control (see 14 CLINICAL TRIALS).

1 INDICATIONS AND USAGE TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

TRULICITY ® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated ( 1 ):

As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Limitations of Use:

Type 2 Diabetes Mellitus Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes.

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