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Insulin degludec trials yield positive results

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A combination treatment containing ultra-long-acting insulin degludec and insulin aspart enhanced glucose control and reduced the risk of hypoglycemia, while insulin degludec alone also allowed for more flexible dosing regimens, according to phase 3 results published in a financial report released by Novo Nordisk.

For a randomized, controlled, phase 3 trial conducted in three continents, researchers administered the novel combination treatment (DegludecPlus, Novo Nordisk) or insulin aspart alone (NovoMix 30, Novo Nordisk) twice daily to study participants. Results indicated that combination insulin degludec and insulin aspart boosted glycemic control and was noninferior to insulin aspart alone in decreasing HbA1c.

In addition, the researchers reported faster achievement of titration targets, as well as lower fasting and mean plasma glucose levels in the combination treatment arm. Total daily insulin dose was also lower at the study’s conclusion compared with the insulin aspart alone group, and combination treatment appeared to significantly decrease the overall rate of confirmed hypoglycemia. The rate of nocturnal hypoglycemia was also reduced by more than two-thirds.

The novel combination treatment appeared safe and tolerance, with no differences between the two treatment arms.

Another randomized, controlled phase 3 trial compared insulin degludec alone with insulin glargine (Lantus, Sanofi-Aventis) for the treatment of patients with type 2 diabetes. Patients were randomly assigned to one of three treatment groups: insulin degludec administered in a flexible dosing regimen, with intervals between doses ranging from 8 to 40 hours; insulin degludec in the evening; or insulin glargine according to its label indication.

Both of the insulin degludec dosing regimens appeared noninferior to insulin glargine in reducing HbA1c, and the researchers reported no differences between the two insulin degludec dosing groups. The flexible dosing regimen, however, was superior to insulin glargine in decreasing the fasting glucose level, according to information in the report.

The researchers also noted a seemingly lower risk of nocturnal hypoglycemia among the insulin degludec treatment groups. Overall, treatment demonstrated a good safety and tolerability profile, preliminary data suggest.

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