Findings from a Phase 3b study showed that Trulicity (dulaglutide; Eli Lilly) added to a sodium-glucose co-transporter-2 (SGLT-2) inhibitor significantly improved A1c levels in patients with type 2 diabetes. Data were published in The Lancet Diabetes & Endocrinology.

The AWARD-10 study (N=424) was a double-blind, parallel-arm, placebo-controlled, 24-week study that compared Trulicity 0.75mg and 1.5mg in combination with SGLT-2 inhibitors vs. placebo plus SGLT-2 inhibitors in patients with type 2 diabetes inadequately controlled with SGLT-2 inhibitors, with or without metformin. The primary objective was to demonstrate the superiority of Trulicity plus an SGLT-2 inhibitor vs. placebo plus an SGLT-2 inhibitor on A1c reduction.

At Week 24 (primary endpoint), both Trulicity 0.75mg and 1.5mg added to ongoing SGLT-2 inhibitor therapy showed statistically superior glycemic control (-1.21% and -1.34%, respectively) vs an SGLT-2 inhibitor plus placebo (-0.54%). Also, significantly more patients treated with Trulicity met their target A1c levels of <7% (0.75mg: 60%; 1.5mg: 71%) and A1c ≤6.5% (0.75mg: 38%; 1.5mg: 50%) vs. placebo (32% and 14%, respectively). 

When Trulicity 1.5mg was added to SGLT-2 inhibitor therapy, there was a greater average weight loss vs. palcebo (-3.1kg vs 2.1kg). Patients in the Trulicity 0.75mg group demonstrated a -2.6kg average weight reduction. 

Regarding safety, the most commonly seen adverse reactions in the Trulicity groups were nausea., vomiting, and diarrhea, as compared to placebo. 

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Trulicity, a glucagon-like peptide-1 (GLP-1) receptor agonist, is currently approved as adjunct to diet and exercise to improve blood glucose in adults with type 2 diabetes. It is available as 0.75mg/0.5mL and 1.5mg/0.5mL strength solutions for subcutaneous (SC) injection in pens or prefilled syringes.

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