Once-weekly Semaglutide 2.0 mg Bests 1.0 mg Dose for A1c, Weight Reduction

The GLP-1 receptor agonist (RA) semaglutide once-weekly at a dose of 2 mg showed a statistically significant and superior reduction in A1c and body weight vs once-weekly semaglutide dosed at 1.0 mg, according to a news release on Tuesday from manufacturer Novo Nordisk.

The topline results are from the phase 3b SUSATIN FORTE trial, a 40-week safety and efficacy study with the 2 doses of semaglutide as treatment intensification for more than 900 patients with type 2 diabetes on metformin or/or a sulfonylurea and not at A1c goal.

When treatment was taken as intended and starting from a mean baseline high A1c of 8.9%, people treated with semaglutide 2.0 mg achieved a statistically significant and superior reduction in A1c of 2.2% vs a reduction of 1.9% with semaglutide 1.0 mg at week 40.

The American Diabetes Association (ADA) treatment target of a1c below 7.0% was achieved by 68% of people treated with semaglutide 2.0 mg vs 58% treated with semaglutide 1.0 mg.
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Superior weight reduction

From a mean baseline body weight of 99.3 kg, people treated with semaglutide 2.0 mg experienced a statistically significant and superior weight loss of 6.9 kg vs 6.0 kg with semaglutide 1.0 mg.

When applying the treatment policy estimand, people treated with semaglutide 2.0 mg experienced a reduction in A1c of 2.1% vs 1.9% for people treated with 1.0 mg dose at week 40.

People treated with semaglutide 2.0 mg experienced a statistically non-significant weight loss of 6.4 kg compared with 5.6 kg with semaglutide 1.0 mg.

Both doses of semaglutide appeared safe and well tolerated with gastrointestinal side effects the most commonly reported; most were mild to moderate and diminished over time, consistent with the GLP-1 RA class.

“We are very pleased with the results from the SUSTAIN FORTE trial with the large HbA1c reduction from a high baseline as well as the safety and tolerability profile, which establish [an] attractive benefit-risk ratio for treatment of type 2 diabetes with semaglutide” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk in the company announcement.

“Semaglutide 1.0 mg has across the SUSTAIN programme demonstrated that up to 80% of patients achieved HbA1c levels below 7%. This study demonstrates that patients in poor glycaemic control increase the likelihood of achieving their HbA1c target when treated with semaglutide 2.0 mg.”