From the FDA Drug Label
TRULICITY has been studied in adults as monotherapy and in combination with metformin, sulfonylurea, metformin and sulfonylurea, metformin and thiazolidinedione, sodium-glucose co-transporter-2 inhibitors (SGLT2i) with or without metformin, basal insulin with or without metformin, and prandial insulin with or without metformin All other clinical studies in adults evaluated TRULICITY 0.75 mg and 1.5 mg without dose escalation; patients were initiated and maintained on either 0.75 mg or 1. 5 mg for the duration of the trials In a double-blind trial with primary endpoint at 26 weeks, 807 adult patients inadequately treated with diet and exercise, or with diet and exercise and one antidiabetic agent used at submaximal dose, were randomized to TRULICITY 0.75 mg once weekly, TRULICITY 1. 5 mg once weekly, or metformin 1500 to 2000 mg/day following a two-week washout.
Trulicity 1.5mg can be used without Metformin as it has been studied as monotherapy in adults with type 2 diabetes mellitus. The clinical trials evaluated TRULICITY 0.75 mg and 1.5 mg without dose escalation, and patients were initiated and maintained on either dose for the duration of the trials 1.
From the Research
Trulicity (dulaglutide) 1.5mg can be used without Metformin (metformin hydrochloride) in certain situations, as it is FDA-approved as a standalone therapy for type 2 diabetes. The standard dosing starts at 0.75mg once weekly by subcutaneous injection, potentially increasing to 1.5mg weekly if needed for better glycemic control, as shown in studies such as 2. While combination therapy with Metformin is common and often preferred as first-line treatment due to complementary mechanisms of action, some patients cannot tolerate Metformin due to gastrointestinal side effects or may have contraindications such as severe kidney disease. In these cases, Trulicity monotherapy is appropriate, as it has been shown to be effective in improving glycemic control and reducing body weight, with a low inherent risk of hypoglycemia, as demonstrated in studies like 3. Trulicity works by mimicking the incretin hormone GLP-1, which stimulates insulin secretion, suppresses glucagon release, slows gastric emptying, and reduces appetite. Some key points to consider when using Trulicity without Metformin include:
- The potential for gastrointestinal side effects, such as nausea, vomiting, and diarrhea, which typically improve over time, as noted in 4 and 5.
- The importance of regular monitoring of blood glucose levels to ensure adequate glycemic control, as emphasized in 6.
- The potential benefits of Trulicity in reducing the risk of major adverse cardiac events, as shown in the REWIND CV outcomes trial, as discussed in 3. Overall, Trulicity 1.5mg can be a useful option for patients with type 2 diabetes who cannot tolerate Metformin or have contraindications to its use, and its efficacy and safety profile make it a valuable treatment option, as supported by the most recent and highest quality study, 2.