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GLP-1 Agonist Semaglutide Completes Phase III Trial with Positive Results

Data establishes effectiveness of semaglutide in treatment of type 2 diabetes….

Novo Nordisk is currently the manufacturer for Victoza (liraglutide), a GLP-1 agonist that needs to be injected once daily. However, semaglutide only needed to be taken once weekly, which is more preferred.

The main objective of the SUSTAIN-3 trial was to evaluate the efficacy and safety of 0.5mg and 1.0mg semaglutide as a monotherapy compared with placebo for a treatment period of 30 weeks. The trial was conducted in a total of 388 people with type 2 diabetes with A1c of 8.1% at baseline. The participants were randomized to receive 0.5mg, 10mg or placebo.

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Results showed that 74% of patients in the 0.5 group and 73% patients in the 1.0mg achieved A1c below 7% compared to only 25% of the placebo group. A reduction of 1.5% and 1.6% in A1c was observed in the 0.5mg and 1.0mg, respectively. Furthermore, from a mean baseline of 92 kg, people treated with semaglutide in either doses of 0.5 mg or 1.0 mg experienced a superior weight loss of 3.8 kg and 4.6 kg, respectively, compared with a weight loss of 1.0 kg for people treated with placebo.

No major adverse effects were reported; the discontinuation rate was 6% in 0.5mg group and 5% in the 1.0mg group. Most common adverse events were primary gastrointestinal upset and usually resolved over time.

“We are excited about these results,” said Mads Krogsgaard Thomsen, an executive vice president and chief science officer of Novo Nordisk. “We look forward to further results from the SUSTAIN clinical development program.”

Practice Pearls:

  • Semaglutide is a long-acting GLP-1 agonist that required injection once a week.
  • Roughly 75% of the participants had their A1c reduced to less than 7% with semaglutide injection once weekly for 30-week study trial.
  • Approximately 4-5 kg weight loss was also observed in patients taking semaglutide. Common side effect is diarrhea, but diminished over time.

“Novo Nordisk A/S. Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes (SUSTAIN™1).” ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2015 July 24]. Available from: https://clinicaltrials.gov/ct2/show/NCT02054897.