In Head-to-Head Trial, Ozempic Tops Trulicity

Novo Nordisk drug found superior for diabetes, weight control

Once-weekly semaglutide (Ozempic, Novo Nordisk) led to greater reductions in HbA1c and body weight compared to dulaglutide (Trulicity, Eli Lilly) in the SUSTAIN 7 trial, according to results published in The Lancet Diabetes & Endocrinology.

SUSTAIN 7 investigated the efficacy and safety of 0.5 mg semaglutide compared with 0.75 mg dulaglutide and 1.0 mg semaglutide compared with 1.5 mg dulaglutide, when added to metformin. The 40-week trial was conducted among people with type-2 diabetes.

"SUSTAIN 7 is an important head-to-head trial, demonstrating significant efficacy of once-weekly semaglutide versus dulaglutide," said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk.

From a mean baseline of 8.2%, HbA1c was reduced by 1.5% with semaglutide 0.5 mg compared to 1.1% with dulaglutide 0.75 mg. At the high doses, semaglutide 1.0 mg reduced HbA1c by 1.8% compared to 1.4% with dulaglutide 1.5 mg. The estimated treatment difference was statistically significant in both the low-dose and high-dose comparisons at –0.40% and –0.41%, respectively. The HbA1c and body weight reductions achieved with semaglutide in SUSTAIN 7 were consistent with those results observed in the other efficacy studies in the SUSTAIN clinical trial program.

Using the American Diabetes Association (ADA) treatment target of HbA1c below 7.0%, significantly more people treated with semaglutide compared with dulaglutide, at both dose levels, achieved the ADA treatment target (68% and 79% on 0.5 mg and 1.0 mg semaglutide versus 52% and 67% on 0.75 mg and 1.5 mg dulaglutide).

Furthermore, from a mean baseline of 95.2 kg, body weight was reduced by 4.6 kg in people treated with semaglutide 0.5 mg compared with 2.3 kg in people treated with dulaglutide 0.75 mg, and by 6.5 kg in people treated with semaglutide 1.0 mg compared with 3.0 kg in people treated with dulaglutide 1.5 mg.

The overall safety profiles of semaglutide and dulaglutide were similar in SUSTAIN 7. Gastrointestinal disorders were the most frequently reported adverse events.

SUSTAIN 7 is a phase 3b, 40-week, efficacy and safety trial of 0.5 mg semaglutide (n = 301) versus 0.75 mg dulaglutide (n = 299) and 1.0 mg semaglutide (n = 300) versus 1.5 mg dulaglutide (n = 299), both once weekly, as add-on to metformin in 1,201 people with type-2 diabetes.

Semaglutide is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1) that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, while decreasing appetite and food intake.

Source: Novo Nordisk; February 1, 2018.

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