Munich: Danish Drug maker Novo Nordisk recently announced that patients treated with Semaglutide, an investigational glucagon-like peptide 1 analogue administered once-weekly, reduces the risk of cardiovascular problems by 26% among type 2 Diabetic patients with high CV risk.

Semagutide significantly reduced the risk of the primary composite endpoint of time to first occurrence of either cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 26% vs placebo, when added to standard of care in 3,297 adults with type 2 diabetes at high CV risk, the drug maker company said.

This was announced by Steven P Marso, Medical Director, Cardio Vascular Services, HCA Midwest Health, US, and the principal investigator of 3200-patient SUSTAIN trials conducted in 22 countries, while presenting the main results of the trial at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016 held recently at Munich, Germany. The results have also been published in the New England Journal of Medicine.

The lower cardiovascular risk was principally driven by a significant 39% decrease in nonfatal stroke and a 26% reduction in nonfatal MI (nonsignificant); there was no difference in cardiovascular deaths between the different arms of the trial - 0.5 mg of semaglutide once weekly, 1.0 mg of semaglutide once weekly, and corresponding placebo groups.

"The reduction in cardiovascular events observed with semaglutide in SUSTAIN 6 is notable given the small study population and the short trial duration," said Dr Marso. "These findings are clinically relevant, as cardiovascular disease is the leading cause of death in people with type 2 diabetes and new treatment options that can also reduce the risk of cardiovascular events are needed."

"The results of SUSTAIN 6 support the strong potential of once-weekly semaglutide in type 2 diabetes treatment and we look forward to regulatory submission later this year," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "The SUSTAIN 6 results further strengthen the clinical evidence for the Novo Nordisk GLP-1 receptor agonist portfolio with the finding of additional benefits beyond glycaemic control and weight loss in adults with type 2 diabetes at high cardiovascular risk."

Semaglutide was also a potent glucose-lowering agent, with significant and sustained reductions in HbA1c levels seen with the agent, as compared with placebo, and similar rates of hypoglycemia, although glucose lowering was not the main point of the trial.

However, one problem that was noticed was that patients in the semaglutide arm were more likely to develop problems with diabetic retinopathy, an eye disorder that can cause blindness. Significantly more people treated with semaglutide (50 [3.0%]) vs placebo (29 [1.8%]) experienced diabetic retinopathy complications.

Novo Nordisk has announced that semaglutide significantly improved glycemic control compared to placebo, as add on to basal insulin or in combination with metformin.
Presenting the results of SUSTAIN 5 trials, the company said the improvement in glycemic control was found among adults with a mean type 2 diabetes duration of 13 years. The 30-week trial showed that adults with type 2 diabetes treat with 0.5 mg and 1.0 mg semaglutide achieved superior weight loss and statistically significant and superior HbA1c reductions.

"Adding once weekly semaglutide to basal insulin or combination with metformin can help people achieve glycemic control and weight loss," said Dr Helena Rodbard, SUSTAIN 5 investigator and Medical Director, Endocrine and Metabolic consultants, Rockville. "I am encouraged by these findings as many people with long standing type 2 diabetes experience suboptimal glucose control and weight gain," she added.