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. These data, from the Trulicity AWARD-8 clinical trial, were presented for the first time today at the 2015 International Diabetes Federation (IDF) World Diabetes Congress in Vancouver, Canada.
"For patients who cannot tolerate or have contraindications to metformin, a sulfonylurea is often prescribed as first-line therapy for type 2 diabetes," said Kathleen Dungan, M.D., endocrinologist, associate professor, The Ohio State University Wexner Medical Center, and lead study author. "This study affirms that Trulicity is efficacious and well-tolerated as an add-on to sulfonylurea therapy, which can help prescribers make treatment decisions for their individual patients."
At the primary endpoint of 24 weeks, Trulicity 1.5 mg plus sulfonylurea provided superior A1C reduction from baseline (-1.38 per cent) compared to sulfonylurea with placebo (-0.11 per cent). 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 per cent) and diarrhea (8.4 per cent). 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 per cent) and there were no reported cases of severe hypoglycemia in either group.
"The AWARD-8 study demonstrated Trulicity's safety and efficacy as add-on therapy to sulfonylurea," said Jessie Fahrbach, M.D., medical director, Lilly Diabetes. "These data add to the comprehensive body of evidence for Trulicity, reinforcing its value as a type 2 diabetes treatment option."
This phase 3, randomized, double-blind, placebo-controlled, 24-week study compared the efficacy and safety of once-weekly Trulicity 1.5 mg to placebo in sulfonylurea-treated patients with type 2 diabetes and inadequate glycemic control. The primary objective of the study, in 299 patients with a mean baseline A1C of 8.4 per cent, was to demonstrate superiority of Trulicity 1.5 mg to placebo on A1C reduction in patients treated with sulfonylurea monotherapy.
Trulicity is a once-weekly injectable prescription medicine to improve blood sugar in adults with type 2 diabetes. It should be used along with diet and exercise.
Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas. Trulicity should not be used by people with a history of severe gastrointestinal disease, people with type 1 diabetes, or people with diabetic ketoacidosis. It is not a substitute for insulin. It has not been studied with long-acting insulin or in children under 18 years of age.
Approximately 29 million Americans and an estimated 415 million people worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 per cent of all diabetes cases. Diabetes is a chronic disease that occurs when the body does not either properly produce or use the hormone insulin.