Novo Nordisk announced headline results Tuesday from the Phase IIIa PIONEER 2 trial showing that a once-daily oral formulation of its GLP-1 analogue Ozempic (semaglutide) led to superior improvement in HbA1c levels in adults with type 2 diabetes, compared with Eli Lilly and Boehringer Ingelheim's SGLT-2 inhibitor Jardiance (empagliflozin). Mads Krogsgaard Thomsen, chief science officer of Novo Nordisk, described the PIONEER 2 results as an "important milestone" in the clinical development of oral Ozempic.

In the study, 816 patients with type 2 diabetes inadequately controlled on metformin were randomly assigned to once-daily treatment with Ozempic or with Jardiance for 52 weeks. Confirmatory endpoints were change in HbA1c and body weight from baseline to week 26, while key secondary goals included change in HbA1c and body weight from baseline to week 52. Novo Nordisk noted that the PIONEER 2 data were analysed via a primary statistical approach required by recent regulatory guidance evaluating efficacy irrespective of discontinuation of treatment and use of rescue medication, as well as a secondary statistical approach describing the effect while on treatment and without use of rescue medication.

Novo Nordisk said that when applying the primary statistical approach, PIONEER 2 achieved its main objective of significant improvement in HbA1c with oral Ozempic versus Jardiance at 26 weeks, although the difference in weight loss between the two groups at this time point was not significant.

Using the secondary statistical approach, HbA1c levels were significantly reduced by 1.4 percent at 26 weeks and 1.3 percent at 52 weeks in the oral Ozempic group, compared to respective HbA1c improvements of 0.9 percent and 0.8 percent with Jardiance. Moreover, 72 percent of Ozempic-treated patients and 47 percent of those on Jardiance reached the American Diabetes Association treatment target of HbA1c below 7 percent at 52 weeks. Further, Ozempic was associated with weight loss of 4.2 kg at 26 weeks, as well as a significant 4.7 kg at 52 weeks, compared to 3.8 kg at both time points among patients treated with Jardiance.

The FDA approved a once-weekly subcutaneous version of Ozempic in December for the treatment of adults with type 2 diabetes, while regulators in Europe and Canada cleared the injectable formulation for the same indication earlier this year. 

Novo Nordisk said it intends to complete all 10 studies in the Phase III PIONEER programme this year, and hopes to launch the oral therapy in 2020.

Meanwhile, the FDA approved Jardiance in 2014 to improve glycaemic control in adults with type 2 diabetes. The agency later expanded the drug's indication to include reducing the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease

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