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Novo Nordisk presents new findings for Tresiba and semaglutide
13 June 2016 • Author: Victoria White, Digital Content Producer
Novo Nordisk has presented new findings from separate studies of Tresiba (insulin degludec injection U-100) and semaglutide (an investigational glucagon-like peptide-1 (GLP-1) analogue) at the American Diabetes Association 76th Scientific Sessions.
New findings from the two Phase IIIb SWITCH trials showed that treatment with long-acting basal insulin Tresiba resulted in significantly lower rates of overall, nocturnal and severe hypoglycaemia compared with insulin glargine U-100.
In SWITCH 1, patients with type 1 diabetes taking Tresiba compared with insulin glargine U-100 experienced: a rate reduction of 11% in overall symptomatic blood glucose (BG) confirmed hypoglycaemic episodes; a rate reduction of 36% in nocturnal BG confirmed symptomatic hypoglycaemic episodes, and a rate reduction of 35% severe hypoglycaemia during the maintenance period. All of the above analyses showed similar results in the full treatment period.
In SWITCH 2, patients with type 2 diabetes taking Tresiba compared with insulin glargine U-100 experienced a rate reduction of 30% in overall BG confirmed symptomatic hypoglycaemic episodes and a rate reduction of 42% in nocturnal BG confirmed symptomatic hypoglycaemic episodes. The above analyses showed significant results in the full treatment period.
In the maintenance period, there was a trend towards lower rates of severe hypoglycaemia in favour of Tresiba vs insulin glargine U-100. In the full treatment period, a significant 51% rate reduction in severe hypoglycaemia was observed in patients receiving Tresiba vs insulin glargine U-100.
Commenting on the Tresiba results, Dr Wendy Lane, lead SWITCH 1 study investigator and clinical endocrinologist at Mountain Diabetes and Endocrine Centre, said: “Hypoglycaemia is an ongoing challenge for people with type 1 and type 2 diabetes. These findings are important for the diabetes community, and add to the existing body of evidence for Tresiba.”
Semaglutide in type 2 diabetes
Findings from two Phase IIIa clinical trials for semaglutide were also presented at the American Diabetes Association 76th Scientific Sessions.
In the SUSTAIN 2 trial, 0.5 mg and 1.0 mg semaglutide administered once-weekly significantly improved glycaemic control compared to sitagliptin (100 mg), a dipeptidyl peptidase-4 (DPP-4) inhibitor, in adults with type 2 diabetes. In the SUSTAIN 3 trial, 1.0 mg semaglutide administered once-weekly significantly improved glycaemic control compared to 2.0 mg exenatide extended-release (ER), a GLP-1 receptor agonist, in adults with type 2 diabetes.
The SUSTAIN 2 trial showed that from a mean baseline HbA1c of 8.1%, adults with type 2 diabetes treated with 0.5 mg and 1.0 mg semaglutide achieved superior HbA1c reductions of 1.3% and 1.6%, respectively, vs 0.5% with 100 mg sitagliptin at 56 weeks as add-on to metformin and/or thiazolidinediones.
In the 56-week SUSTAIN 3 trial, adults with type 2 diabetes and a mean baseline HbA1c of 8.3% achieved a superior HbA1c reduction of 1.5% when treated with 1.0 mg semaglutide vs 0.9% with 2.0 mg exenatide ER as add-on to one or two oral antidiabetics (metformin, sulfonylurea or thiazolidinediones).
More adults with type 2 diabetes achieved the HbA1c target of <7% when treated with 0.5 mg and 1.0 mg semaglutide vs sitagliptin in SUSTAIN 2 (69% and 78% vs 36%) and with 1.0 mg semaglutide vs exenatide ER in SUSTAIN 3 (67% vs 40%).
In addition, from a mean baseline body weight of 89.5 kg, adults with type 2 diabetes achieved significantly greater reductions in mean body weight when treated with 0.5 mg and 1.0 mg semaglutide vs sitagliptin in SUSTAIN 2 (4.3 kg and 6.1 kg vs 1.9 kg). Similarly, from a mean baseline body weight of 95.8 kg, adults with type 2 diabetes achieved significantly greater reductions in mean body weight when treated with 1.0 mg semaglutide vs exenatide ER in SUSTAIN 3 (5.6 kg vs 1.9 kg).
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