A new drug called dulaglutide is expected to hit the market and serve as a possible alternative to metformin, which helps treat Type 2 diabetes.
A study funded by Eli Lilly and Company, the global pharmaceutical company that developed dulaglutide, showed that the drug improves glycemic control in patients with early-stage Type 2 diabetes and may be an appropriate option for some patients who are not candidates for metformin therapy. More specifically, treatment with dulaglutide, a long-acting GLP-1 receptor agonist, led to a greater decrease in a patient's hemoglobin A1c (HbA1c) compared to metformin.
"The first line of therapy for most patients with type 2 diabetes is metformin," lead author Dr. Guillermo Umpierrez of Emory University in Atlanta told Reuters Health. "Dulaglutide is more effective than DPP4-inhibitors and is not associated with the increased risk of hypoglycemia like sulfonylureas, so it is the ideal second-line agent for most patients with type 2 diabetes."
The 52-week study recruited 807 patients who had Type 2 diabetes for more than three months but less than five years. Participants were required to have a baseline HbA1c between 6.5 percent and 9.5 percent, and had to be treated with diet and exercise alone or one oral antihyperglycemic medication. Then they were randomly assigned to receive either weekly injections of dulaglutide, 1.5 milligrams or 0.75 milligrams, or metformin plus an injection placebo.
After 26 weeks, results showed that the groups treated with 1.5 milligrams and 0.75 milligrams of dulaglutide had a substantially larger decrease in HbA1c compared to the groups treated with metformin (0.78 percent, 0.71 percent, and 0.56 percent respectively; p
Furthermore, there were similar decreases in body weight in patients treated with 1.5 milligrams of dulaglutide and those treated with metformin.
The most common side effects included nausea, vomiting and diarrhea. Incidences of these events did not differ greatly between the groups, and no severe hypoglycemic events were reported.
Dulaglutide: The new top choice?
Lilly believes dulaglutide has the data to break through the noise and become the drug of choice among early Type 2 diabetics. However, Dr. Seth Berkowitz, an endocrinologist at Massachusetts General Hospital in Boston, believed the study was too short-sighted.
"Because the study did not look at long-term outcomes like preventing diabetes complications (eye, kidney, or heart disease), which metformin has been shown to do, it does not provide enough evidence to select routinely dulaglutide over metformin for single-agent therapy of diabetes," Berkowtiz told Reuters. "While it is certainly a valuable contribution to have another agent for blood sugar lowering, metformin will likely remain the preferred first-line agent because of its proven track record of long-term benefits and safety, much lower cost, and convenience."
Dulaglutide has been submitted for approval to the U.S. Food and Drug Administration, the European Medicines Agency and other regulatory organizations. If approved, it will be marketed as Trulicity.