What is the effect of Trulicity (Dulaglutide)?

From the Guidelines

Trulicity (dulaglutide) should be initiated at a dose of 0.75 mg subcutaneously once weekly and titrated as tolerated to 1.5 mg or maximally tolerated dose based on prescribing information, as it has been shown to improve glycemic control and reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes 1.

Key Considerations

• The medication belongs to the GLP-1 receptor agonist class, which works by stimulating insulin release, reducing glucagon secretion, slowing stomach emptying, and decreasing appetite.
• Common side effects include nausea, vomiting, diarrhea, and abdominal pain, which typically improve over time.
• Trulicity offers cardiovascular benefits and may assist with weight loss, making it a valuable option for patients with type 2 diabetes.
• Patients with a personal or family history of medullary thyroid carcinoma or those with Multiple Endocrine Neoplasia syndrome type 2 should not use this medication.

Dosage and Administration

• The standard starting dose is 0.75 mg injected subcutaneously once weekly.
• The dose can be increased to 1.5 mg weekly if needed for better blood sugar control.
• Trulicity comes in a pre-filled pen that doesn't require dose measuring and can be injected in the abdomen, thigh, or upper arm.

Benefits and Risks

• Trulicity has been shown to improve glycemic control and reduce the risk of MACE in patients with type 2 diabetes 1.
• The medication may also assist with weight loss and offer cardiovascular benefits.
• However, patients should be aware of the potential risks, including nausea, vomiting, diarrhea, and abdominal pain, as well as the rare but serious risk of thyroid C-cell tumors and pancreatitis.

Patient Selection

• Trulicity is suitable for patients with type 2 diabetes who require improvement in glycemic control and are at risk for MACE.
• Patients with a history of serious hypersensitivity reaction to the drug, pregnancy or breast feeding, severe renal impairment or end-stage renal failure, or personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2 should not use this medication.

Monitoring and Follow-up

• Patients should be monitored for signs and symptoms of pancreatitis, thyroid C-cell tumors, and other adverse effects.
• Regular follow-up appointments should be scheduled to assess glycemic control, cardiovascular risk, and potential side effects.

From the FDA Drug Label

1. 6 Renal Impairment TRULICITY has been studied in patients with varying degrees of renal function, including a dedicated clinical trial in patients with moderate to severe chronic kidney disease. No overall differences in safety or effectiveness were observed in these studies according to renal function [see Clinical Studies (14.2,14.3,14. 4)]. In a clinical pharmacology study in patients with renal impairment, including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. In the 52-week trial in patients with type 2 diabetes and moderate to severe renal impairment, the PK behavior of TRULICITY 0.75 mg and 1. 5 mg once weekly was similar to that demonstrated in previous clinical studies [see Clinical Pharmacology (12. 3)]. No dose adjustment is recommended in patients with renal impairment including end-stage renal disease (ESRD). Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Use TRULICITY with caution in patients with ESRD [see Warning and Precautions (5.5), Clinical Pharmacology (12.3)].

Trulicity does not require dose adjustment in patients with renal impairment, including end-stage renal disease (ESRD) 2. However, it is recommended to monitor renal function in patients with renal impairment who report severe adverse gastrointestinal reactions and to use with caution in patients with ESRD.

From the Research

Overview of Trulicity

• Trulicity, also known as dulaglutide, is a once-weekly subcutaneously administered glucagon-like peptide-1 (GLP-1) receptor agonist used for the treatment of type 2 diabetes 3.
• It is approved in numerous countries as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes (T2DM) 3, 4.

Efficacy of Trulicity

• Dulaglutide has been shown to be effective in improving glycemic control and reducing body weight in patients with type 2 diabetes 3, 4, 5.
• In clinical trials, dulaglutide was noninferior to once-daily liraglutide and significantly more effective than once-daily oral sitagliptin, twice-daily subcutaneous exenatide, and once-daily subcutaneous insulin glargine in terms of improvements in glycated hemoglobin from baseline at 26 or 52 weeks 3.
• Dulaglutide 1.5 mg once weekly, but not 0.75 mg once weekly, was associated with consistent reductions in body weight from baseline 3.

Safety Profile of Trulicity

• Dulaglutide was generally well tolerated, with a low inherent risk of hypoglycemia 3, 5.
• The most frequently reported adverse events in clinical trials were gastrointestinal-related (e.g., nausea, vomiting, and diarrhea) 3, 6.
• Higher doses of dulaglutide (3.0 and 4.5 mg) were evaluated for safety and efficacy, and the safety profiles were consistent with the established safety profile for dulaglutide 6.

Cardiovascular Benefits of Trulicity

• Dulaglutide was associated with a significant reduction in the risk of a major adverse cardiac event (MACE) at a median of 5.4 years' follow-up in the REWIND CV outcomes trial 5.
• GLP-1 receptor agonists, including dulaglutide, have been shown to effectively prevent CV events such as acute myocardial infarction or stroke and associated mortality 7.