New data from a completed Phase 3 trial show Trulicity (dulaglutide) 1.5 mg plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering hemoglobin A1c (A1C) from baseline after 24 weeks of treatment. Trulicity is Eli Lilly and Company's once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes.
At the primary endpoint of 24 weeks, Trulicity 1.5 mg plus sulfonylurea provided superior A1C reduction from baseline (-1.38 percent) compared to sulfonylurea with placebo (-0.11 percent). Additionally:
- Significantly more patients treated with Trulicity 1.5 mg plus sulfonylurea achieved an A1C of less than 7 percent (55.3 percent) compared to sulfonylurea with placebo (18.9 percent); and
- Trulicity plus a sulfonylurea significantly reduced fasting serum glucose levels (the amount of sugar in the blood in a fasting state) compared to sulfonylurea with placebo (-30.60 mg/dL vs. +2.93 mg/dL).
As a secondary endpoint of the study, Trulicity plus a sulfonylurea showed weight reduction from baseline (-0.91 kg), though the difference compared to sulfonylurea with placebo did not reach statistical significance.
The most commonly reported adverse events were gastrointestinal-related and consistent with prior Trulicity studies, including nausea (10.5 percent) and diarrhea (8.4 percent). There were no cases of pancreatitis or pancreatic cancer in either treatment group. As expected, more patients treated with Trulicity plus a sulfonylurea experienced episodes of hypoglycemia compared to those treated with sulfonylurea alone, though the overall incidence of documented symptomatic hypoglycemia was low in the Trulicity group (11.3 percent) and there were no reported cases of severe hypoglycemia in either group.
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