Lilly Korea said Tuesday that its Trulicity (ingredient name: dulaglutide), a once-weekly GLP-1 analog, had won the regulatory go-ahead as a combination therapy with basal insulin for type 2 diabetic patients.
The licensed dose is 0.75mg in low dose and 1.5mg in high dose, and it is possible to customize treatment according to patient's condition such as blood glucose level in domestic diabetic patients, the company said.
The Ministry of Food and Drug Safety approved it based on the results of the AWARD-9 clinical study, which included 300 patients with type 2 diabetes who did not achieve the target HbA1c, 1.5 mg of Trulicity versus placebo plus insulin glargine versus metformin. It is a randomized, double-blind, placebo-controlled, 28-week phase 3 clinical trial evaluating the efficacy and safety of combination therapy.
After 28 weeks of treatment, the Triglycoside 1.5 mg versus baseline versus insulin glargine (1.44 percent) group showed a significantly lower HbA1c level compared to placebo plus insulin glargine (0.67 percent).
"In a diabetic patient receiving long-term insulin therapy, we can see that increasing insulin does not control blood sugar," said Professor Cho Young-min of Internal Medicine of Seoul National University Hospital. "The combination of insulin and GLP-1 analogs in these patients can help achieve targeted blood glucose levels, reduce insulin use, and minimize the risk of developing hypoglycemia. Therapy will be a new treatment option for people with diabetes who have difficulty controlling their blood sugar with insulin alone.”
Lilly Korea한국릴리 was equally upbeat. "We are pleased to offer a broad range of customized treatment options for diabetics with difficulties," said Lilly Korea President Paul Henry Huibers. "In the future, we will make efforts to contribute to active diabetes patients' aggressive blood glucose management and quality of life through the expansion of insurance coverage of Trulicity and basal insulin therapy."
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