Dulaglutide ( Trulicity ) significantly improves A1C ( average blood sugar concentration over two to three months ) when added to ongoing treatment with a sodium-glucose co-transporter-2 ( SGLT-2 ) inhibitor, according to results from AWARD-10, a new phase 3b clinical study.
These data were published in The Lancet Diabetes & Endocrinology.
Dulaglutide is once-weekly, injectable glucagon-like peptide-1 ( GLP-1 ) receptor agonist approved to improve blood glucose in adults with type 2 diabetes.
Dulaglutide should be used along with diet and exercise.
At the study's primary endpoint of 24 weeks, both Dulaglutide 1.5 mg and 0.75 mg added to ongoing treatment with an SGLT-2 inhibitor demonstrated statistically superior glycemic control ( -1.34%, -1.21% for Dulaglutide 1.5 mg and 0.75 mg, respectively ) compared to an SGLT-2 inhibitor with placebo ( -0.54% ).
Further, significantly more people in the Dulaglutide groups reached target A1C levels of less than 7% and less than or equal to 6.5%: Dulaglutide 1.5 mg: 71% ( less than 7% ); 50% ( less than or equal to 6.5% ); Dulaglutide 0.75 mg: 60% ( less than 7%; 38% ( less than or equal to 6.5% ); Placebo: 32% ( less than 7% ); 14% ( less than or equal to 6.5% ).
Additional results showed that Dulaglutide 1.5 mg combined with an SGLT-2 inhibitor was associated with greater average weight loss ( -3.1 kg ) compared to placebo ( -2.1 kg ).
An average weight reduction of -2.6 kg was seen in the Dulaglutide 0.75 mg group.
The most commonly reported adverse events associated with Dulaglutide were gastrointestinal-related and consistent with previous studies.
Nausea ( 15%, 5%, 4% ), vomiting ( 4%, 3%, 1% ) and diarrhea ( 6%, 10%, 3% ) were more frequent in the Dulaglutide 1.5 mg and 0.75 mg groups compared to placebo.
One severe hypoglycemic event was documented in the Dulaglutide 0.75 mg group.
No new Dulaglutide-related safety concerns were identified. ( Xagena )
Source: Eli Lilly, 2018