pharmatimesAugust 18, 2017
Tag: novo , Semaglutide
In the 40-week, Phase IIIb study, semaglutide 0.5mg achieved a statistically significant and superior reduction in HbA1c of 1.5 percent versus 1.1 percent with 0.75mg dulaglutide (brand name Trulicity).
Simliarly, those given the 1.0mg dose of semaglutide experienced a statistically significant and superior reduction in HbA1c of 1.8 percent compared with a decrease of 1.4 percent recorded for patients taking 1.5mg dulaglutide.
Using the American Diabetes Association treatment target of HbA1c below or equal to 7 percent, 69 percent of people treated with 0.5mg semaglutide compared with 52 percent of people treated with 0.75mg dulaglutide reached the treatment goal, while 79 percent and 68 percent of those taking the respective higher doses were alo on target.
People treated with 0.5mg semaglutide also experienced a statistically significant and superior weight loss of 4.6kg compared to 2.3kg with 0.75mg dulaglutide. People in the 1.0mg semaglutide treatment arm showed a statistically significant and superior weight loss of 6.5kg versus to 3.0kg with 1.5mg dulaglutide.
Semaglutide also ticked safety boxes showing itself to be well tolerated, with the most common adverse event for both dosages mild to moderate nausea, which was overall comparable to dulaglutide and diminished over time. Premature treatment discontinuation due to adverse events was less than 10 percent across all treatment groups, Novo noted.
"The superior glucose control and weight loss achieved with semaglutide compared to dulaglutide in this trial reinforces the unprecedented results observed in the entire SUSTAIN programme," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are excited about the potential of semaglutide to set a new standard for treatment of type II diabetes".
Once-weekly semaglutide is currently under review by seven regulatory agencies, including the US Food and Drug Administration, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
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