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Novo Nordisk presents new findings for Tresiba and semaglutide

Posted: 13 June 2016 | | No comments yet

Novo Nordisk presented new findings from separate studies of Tresiba and semaglutide at the American Diabetes Association 76th Scientific Sessions…

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.

tresiba

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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