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Adults with type 2 diabetes mellitus: Semaglutide has demonstrated superior improvements in glycaemic control vs Sitagliptin and Exenatide ER in two clinical trials


Findings from two phase 3a clinical trials for Semaglutide, an investigational glucagon-like peptide-1 ( GLP-1 ) analogue, were presented at the American Diabetes Association ( ADA ) 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, a GLP-1 receptor agonist, in adults with type 2 diabetes mellitus.
The SUSTAIN 2 trial showed that from a mean baseline HbA1c of 8.1%, adults with type 2 diabetes mellitus 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 ( both p less than 0.0001 ), 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 ( p less than 0.0001 ), as add-on to one or two oral antidiabetics ( Metformin, sulfonylurea or thiazolidinediones ).

More adults with type 2 diabetes mellitus achieved the HbA1c target of less than 7% when treated with 0.5 mg and 1.0 mg Semaglutide versus 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; both p less than 0.0001 ).

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; p less than 0.0001 ).

In SUSTAIN 2, the most common adverse events observed for adults treated with 0.5 mg and 1.0 mg Semaglutide and Sitagliptin were gastrointestinal ( 43.5% and 39.9% vs 23.6% ).
Comparable rates of serious adverse events were observed for all treatment groups ( 7.3% and 7.3% vs 7.1% ). The proportions of adults discontinuing 0.5 mg, 1.0 mg or 100 mg Sitagliptin due to adverse events were 8.1% and 9.5% vs 2.9%, respectively.

Similarly, in SUSTAIN 3, the most common adverse events observed for adults treated with 1.0 mg Semaglutide and Exenatide ER were also gastrointestinal ( 41.8% and 33.3% ).
Fewer adults reported injection site reactions with 1.0 mg Semaglutide ( 1.2% ) compared with Exenatide ER ( 22.0% ).
The rates of serious adverse events observed for adults treated with 1.0 mg Semaglutide compared with Exenatide ER were 9.4% and 5.9%, respectively. The proportions of adults discontinuing due to adverse events were 9.4% and 7.2%.

Semaglutide, administered subcutaneously once-weekly, is an investigational analogue of native human glucagon-like peptide-1 ( GLP-1 ) that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, as well as decreases appetite and food intake. ( Xagena )

Source: Novo Nordisk, 2016

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