Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL) (“Zealand”) informs that new sub-analysis results from the GetGoal-L Phase III clinical study show that reductions in HbA1c with Lyxumia® (lixisenatide), when added to basal insulin, were greatest in patients with type 2 diabetes who had well-controlled baseline fasting plasma glucose (FPG). Reductions in body weight with
Lyxumia®, when added to basal insulin, were also greatest in this group. The new results were presented today in an oral session at the 49th Annual Meeting of the European Association for the Study of Diabetes in Barcelona.
Lixisenatide, a once-daily prandial GLP-1 receptor agonist for the treatment of type 2 diabetes, was invented by Zealand, and is marketed in Europe and Japan by Sanofi (EURONEXT: SAN and NYSE: SNY), who holds global development and commercial rights to the product.
Type 2 diabetes is a progressive disease and patients treated with basal insulin may over time no longer maintain their target HbA1c level (2 to 3 months average blood sugar levels) despite typically sustaining good control of FPG with basal insulin.
For these patients, Lyxumia® can through its predominant effect on post-prandial glucose (PPG, after meal blood sugar) significantly reduce HbA1c in complementary action with basal insulin. A treatment regimen that targets PPG as well as FPG could be an effective way to improve disease management in patients with type 2 diabetes who are not at their target HbA1c despite controlled FPG.
Commenting on the presented results, Zealand’s Chief Executive Officer, David Solomon, said:
“We are delighted to see these further positive data on Lyxumia®, the first peptide medicine invented by Zealand. The data presented today at EASD complement previous findings on the beneficial effects of Lyxumia® in particular in combination with basal insulin. We see Lyxumia® as an important new diabetes medicine with a unique therapeutic profile. Marketed by Sanofi who has a strong global presence and a deep understanding of patient needs in this field, we firmly believe our invention will grow to an important product providing a sustainable revenue stream for our company going forward.” And he added: “To explore the full potential for Lyxumia® in combination with basal insulin, Sanofi is planning to start Phase III development of a single Fixed-ratio Lyxumia®/Lantus® combination product in the first half of 2014. We are convinced that such product holds promise also as a very valuable treatment option for diabetes patients.”
Results of the GetGoal sub-analysis
This sub-analysis examined 496 patients with type 2 diabetes and inadequate glucose control. Results showed that the addition of lixisenatide to basal insulin treatment, with or without metformin (oral anti-diabetic therapy), reduced overall HbA1c, body weight and post-breakfast self-monitored post-prandial glucose in all groups. These effects were greater in patients with relatively well-controlled baseline FPG levels (below or equal to 6.7 mmol/L; FPG in people without diabetes is ~5.5 mmol/L1) compared to those with higher baseline FPG levels (between 6.7 and 8.9 mmol/L, and over 8.9 mmol/L, respectively).
The GetGoal-L sub-analysis abstract is entitled: ‘Therapeutic efficacy of lixisenatide added
to basal insulin is greater when FPG is well-controlled’ (Vidal J, et al. (Abstract no. OP 6)).
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