Dulaglutide is an effective add-on therapy to sodium-glucose cotransporter 2 (SGLT2) inhibitors, with or without metformin, resulting in clinically relevant improvements in glycemic control in patients with inadequately controlled type 2 diabetes (T2D), according to the results of the AWARD-10 study published in the Lancet Diabetes & Endocrinology.
Bernhard Ludvik, MD, from the 1st Medical Department and Karl Landsteiner Institute for Obesity and Metabolic Disorders, Rudolfstiftung Hospital, Vienna, Austria, and colleagues enrolled adults with inadequately controlled T2D and a body mass index of 45 kg/m2 or less, who were taking stable doses of an SGLT2 inhibitor with or without metformin, in this phase 3b, double-blind, parallel-group, placebo-controlled, 24-week study (ClinicalTrials.gov identifier: NCT02597049).
This trial randomly assigned patients to receive subcutaneous injections of dulaglutide 1.5 mg, dulaglutide 0.75 mg, or placebo once per week for 24 weeks. The primary outcome was the change in HbA1c concentration from baseline to 24 weeks.
Between December 7, 2015, and February 3, 2017, 424 patients were randomly assigned to 1 of the 3 treatment groups. The reduction in HbA1c concentration at 24 weeks was greater in patients receiving dulaglutide (least squares mean [LSM] for dulaglutide 1.5 mg, −1.34%; LSM for dulaglutide 0.75 mg, −1.21%) than in patients receiving placebo (LSM, −0.54%, P <.0001 for both).
Serious adverse events occurred in 5 patients in the dulaglutide 1.5-mg group, 3 patients in the 0.75-mg group, and 5 patients in the placebo group. Treatment-emergent adverse events occurred more commonly in those treated with dulaglutide than in those treated with placebo. Most of those events were gastrointestinal, including nausea, diarrhea, and vomiting. One episode of severe hypoglycemia occurred in the dulaglutide 0.75-mg group.
The authors noted that the limitations of the study included its relatively short duration.
“These findings further inform the use of a once weekly GLP-1 receptor agonist in combination with SGLT2 inhibitors in patients with inadequately controlled [T2D],” the study researchers concluded.
Clinical trial NCT02597049 was funded by Eli Lilly and Company.
Ludvik B, Frias JP, Tinahones F, et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial [published online February 23, 2018]. Lancet Diabetes Endocrinol. doi: 10.1016/S2213-8587/(18)30023-8