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Ministry OKs phase-3a clinical trial for new anti-diabetes drug
  • By Lee Hye-seon
  • Published 2018.10.26 14:18
  • Updated 2018.10.26 14:59
  • comments 0

Novo Nordisk said it would conduct phase 3a clinical trial for Ozempic in Korea, too. Ozempic is a semaglutide, the company’s new GLP (glucagon-like peptide)-1 analog and a drug to treat type 2 diabetes through a weekly dose.

The Ministry of Food and Drug Safety has approved the 3a clinical test for “semaglutide” (for injection) applied by Novo Nordisk Korea.

Ozempic (Source: www.ozempicpro.com)

The upcoming clinical trial aims to confirm “the efficacy and safety of semaglutide, which is injected into overweight or obese East Asian subjects once a week.”

The company will conduct it on 40 Korean patients at Seoul St. Mary’s Hospital, Samsung Medical Center, Asan Medical Center, Gangnam Severance Hospital, Seoul National University Bundang Hospital and Pusan National University Yangsan Hospital.

Semaglutide is a GLP-1 analog, which won the approval as a therapy of type-2 diabetes from the U.S. Food and Drug Administration in 2017. Its product name is Ozempic. It is the successor of anti-diabetes treatment Victoza (proper name: liraglutide), a long-acting therapy administered not once a day but once a week.

In 3a trial, Semaglutide showed a statistically meaningful reduction in glycated hemoglobin compared with placebo, sitagliptin (product name: Januvia), and exenatide (product name: Bydureon) in type-2 diabetes patients.

Semaglutide produced weight-reducing effects as Victoza did, and general side effects reported by more than 5 percent of treated patients were nausea, vomiting, diarrhea, stomachache and constipation.

Novo Nordisk is developing semaglutide as oral medication and as the obesity treatment as well. If the company completes the development of oral therapy, the product will likely become the first oral GLP-1 analog.

According to global clinical trials conducted on 700 type-2 diabetes patients for 26 weeks, there were significant differences of glycated hemoglobin between patients treated with oral semaglutide 3mg, 7 mg and 14mg and placebo group.

The glycated hemoglobin of patients treated with semaglutide 3mg, 7mg and 14mg fell by 0.8 percent, 1.3 percent and 1.5 percent, respectively, but those of patients treated with placebo dropped 0.1 percent.

Also, those treated with semaglutide 14 mg showed significant and excellent weight loss. Experimenters found weight reduction in the 7mg and 3 mg groups, which were statistically insignificant, though.

If developed as an oral medication, semaglutide’s targets of competition will likely be DPP-4 inhibitors and SLGT-4 inhibitors

This is because in PIONEER clinical trials – several international tests conducted simultaneously – testers measured the declining effects of glycated hemoglobin through direct comparison of semaglutide, sitagliptin and empagliflozin.

As semaglutide showed weight-losing effects, the company is developing it as an obesity treatment like Saxenda (an anti-obesity medication with similar composition to Victoza), a Nova Nordisk Korea official said.


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