What are the indications for Dulaglutide (Trulicity)?

Indications for Dulaglutide (Trulicity)

Dulaglutide (Trulicity) is primarily indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years and older with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. 1

Primary Indications

1. Glycemic Control:

   • For adults and pediatric patients ≥10 years with type 2 diabetes mellitus
   • As adjunct to diet and exercise
   • Starting dose: 0.75 mg subcutaneously once weekly
   • Can be titrated to 1.5 mg once weekly for additional glycemic control
   • Maximum dose in adults: 4.5 mg once weekly
   • Maximum dose in pediatric patients: 1.5 mg once weekly 1

2. Cardiovascular Risk Reduction:

   • For adults with type 2 diabetes mellitus who have:
     • Established cardiovascular disease OR
     • Multiple cardiovascular risk factors
   • Demonstrated benefit in reducing major adverse cardiovascular events (MACE) 1, 2

Clinical Benefits

• Glycemic efficacy: High to very high glucose-lowering effect 2
• Cardiovascular benefits: Reduces risk of MACE 2
• Renal benefits: Shows benefit for renal endpoints in cardiovascular outcome trials, primarily driven by albuminuria outcomes 2
• Weight effects: Associated with weight loss (intermediate to very high) 2
• Hypoglycemia risk: Low inherent risk when used alone 2, 3

Specific Patient Populations for Consideration

1. Patients with established atherosclerotic cardiovascular disease:

   • Particularly beneficial for those with prior myocardial infarction, ischemic stroke, unstable angina with ECG changes, myocardial ischemia on imaging/stress test, or revascularization of coronary, carotid, or peripheral arteries 2

2. Patients without established cardiovascular disease but with high-risk indicators:

   • Age ≥55 years with coronary, carotid, or lower extremity artery stenosis >50%
   • Left ventricular hypertrophy
   • eGFR <60 mL/min/1.73 m²
   • Albuminuria 2

3. Patients with chronic kidney disease (CKD):

   • Recommended for patients with T2D and CKD who don't meet glycemic targets with metformin and/or SGLT2 inhibitor therapy
   • No dose adjustment required for dulaglutide in kidney disease 2
   • Can be used in patients with eGFR as low as 15 mL/min/1.73 m² 2

4. Patients with NASH/NAFLD:

   • May be considered for patients with type 2 diabetes and non-alcoholic fatty liver disease
   • Has been shown to reduce liver fat content and transaminases 2

Contraindications

• Personal or family history of medullary thyroid carcinoma
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Serious hypersensitivity reaction to dulaglutide or any product components 1

Limitations of Use

• Not studied in patients with history of pancreatitis (consider other antidiabetic therapies)
• Not for treatment of type 1 diabetes mellitus
• Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis 1

Practical Prescribing Algorithm

1. Initial assessment:

   • Confirm type 2 diabetes diagnosis
   • Evaluate cardiovascular risk status
   • Check for contraindications (MEN 2, family history of medullary thyroid carcinoma)
   • Assess gastrointestinal function (avoid in severe gastroparesis)

2. Dosing strategy:

   • Start with 0.75 mg subcutaneously once weekly
   • Can be administered at any time of day, with or without food
   • Inject in abdomen, thigh, or upper arm
   • After at least 4 weeks, can increase to 1.5 mg once weekly if needed for glycemic control
   • In adults, can further increase in 1.5 mg increments to maximum 4.5 mg once weekly 1

3. Monitoring:

   • Glycemic control
   • Weight changes
   • Gastrointestinal side effects (nausea, vomiting, diarrhea)
   • Potential for reduced insulin requirements if used with insulin

Common Pitfalls and Caveats

• Gastrointestinal side effects: Most common adverse events are nausea, vomiting, and diarrhea, typically transient and mild to moderate 3, 4
• Thyroid C-cell tumors: Risk identified in rodents; human relevance not determined 2
• Pancreatitis: Acute pancreatitis has been reported; discontinue if suspected 2
• Diabetic retinopathy: Monitor patients with history of diabetic retinopathy closely 2
• Missed doses: If a dose is missed, administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose 1

Dulaglutide offers significant benefits for glycemic control and cardiovascular risk reduction with a favorable safety profile, making it an important therapeutic option for type 2 diabetes management.