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Positive Phase IIIa Results for Semaglutide in Diabetes

GLP-1 analogue study suggests superiority over exenatide as add-on therapy

People with type-2 diabetes treated with semaglutide as an add-on therapy had a greater improvement in HbA1c than those treated with exenatide in a phase IIIa trial, Novo Nordisk has announced.

The company disclosed headline results from the second phase IIIa trial for semaglutide, SUSTAIN 3. Semaglutide is a new glucagon-like peptide-1 (GLP-1) analogue administered subcutaneously once weekly. The trial investigated the efficacy and safety of 1.0 mg semaglutide compared with 2.0 mg exenatide (Byetta, AstraZeneca) once weekly after 56 weeks of treatment added on to one or two oral antidiabetic drugs in 813 people with type-2 diabetes.

The trial achieved its objective by demonstrating that from a mean baseline HbA1c of 8.4%, people treated with 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.5 percentage points compared with the improvement in HbA1c of 0.9 percentage points with 2.0 mg exenatide once weekly.

Sixty-six percent of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association and European Association for the Study of Diabetes treatment target of HbA1c below 7%, compared with 40% of the people treated with 2.0 mg exenatide once weekly.

Furthermore, from a mean baseline body weight of 96 kg, people treated with 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 5.6 kg, compared with a weight loss of 1.8 kg for people treated with 2.0 mg exenatide once weekly.

In the trial, semaglutide appeared to be safe and well tolerated. The most common adverse event was nausea, which diminished over time. Nausea was reported by 22% of people treated with 1.0 mg semaglutide once weekly compared with 11% of people treated with 2.0 mg exenatide once weekly. The discontinuation rate due to all adverse events for 1.0 mg semaglutide was 9.4% compared with 7.2% for 2.0 mg exenatide.

Novo Nordisk expects to announce headline results of the four remaining SUSTAIN trials within the next few quarters. SUSTAIN is a phase III clinical program comprising six global trials of semaglutide administered once weekly encompassing more than 7,000 people with type 2 diabetes. In addition to SUSTAIN 3, the others are:

  • SUSTAIN 1 — a 30-week efficacy and safety trial of semaglutide versus placebo in 388 drug-naïve people with type-2 diabetes.
  • SUSTAIN 2 — a 56-week efficacy and safety trial of semaglutide versus sitagliptin once daily as add-on to metformin and/or TZD in 1,231 people with type-2 diabetes.
  • SUSTAIN 4 — a 30-week efficacy and safety trial of semaglutide versus insulin glargine once daily as add-on to metformin with or without sulfonylurea in 1,089 insulin-naïve people with type-2 diabetes.
  • SUSTAIN 5 — a 30-week efficacy and safety trial of semaglutide versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in 397 people with type-2 diabetes.
  • SUSTAIN 6 — a two-year trial to evaluate cardiovascular and other long-term outcomes with semaglutide in 3,297 people with type-2 diabetes.

Source: Novo Nordisk; September 25, 2015.

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