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Sep 27, 2013

More Data Suggest Novo’s IDegLira Improves Glycemic Control without Weight Gain

  • The investigational therapy IDegLira—a combination of Novo Nordisk’s Tresiba® (insulin degludec) and Victoza® (liraglutide injection) medications—results in improved glycemic control, as indicated by Phase III data from the DUALT I trial, as well as data from the DUALT II trial.

    Data from the DUALT I trial were presented today at a Barcelona conference (the 49th Annual European Association for the Study of Diabetes) reiterated information presented July 17 at an American Diabetes Association meeting in Chicago. According to this data, IDegLira produces a statistically significant greater reduction in blood sugar levels (HbA1c) compared to insulin degludec or liraglutide alone, with no weight gain and a low rate of hypoglycaemia compared to insulin degludec in adults with type 2 diabetes.

    These results were supported by data from the DUALT II trial. These data show once-daily IDegLira provides statistically greater reductions in postprandial glucose following all three main meals of the day (breakfast, lunch, and dinner) compared to insulin degludec.

    IDegLira is a once-daily, single-administration basal insulin/GLP-1 analogue combination. It is being developed for the treatment of type 2 diabetes in adults. DUALT I, which included around 1,600 people in a 26-week, randomized, open-label trial trial, evaluated IDegLira in people with type 2 diabetes inadequately controlled on oral antidiabetic medications compared to insulin degludec or liraglutide (1.8 mg) alone.

    In DUALT II, around 400 people took part in a 26-week, randomized, double-blinded trial comparing IDegLira and insulin degludec in people with type 2 diabetes inadequately controlled on basal insulin in combination with 1-2 oral anti-diabetic agents. In this trial, the maximum dose of insulin degludec was fixed in both treatment arms to investigate the additional impact of the liraglutide component of IDegLira on glucose control.

    “The efficacy of IDegLira demonstrated by the DUALT I data is exciting. It combines the clinical advantages yet mitigates the principal side-effects of insulin degludec and liraglutide,” said Professor Stephen Gough, University of Oxford and Oxford University Hospitals NHS Trust, lead investigator of the study. “DUALT I shows how patients can achieve an average final HbA1c of 6.4% with no weight gain and a low rate of hypoglycaemia.”

    Presentations at the Barcelona conference about the DUALT II data showed that the effects of IDegLira on fasting and postprandial glucose levels resulted in a substantial overall improvement in glycemic control as compared to its individual components. IDegLira reduced the postprandial increments significantly more than insulin degludec following all three main meals. The reduction in postprandial increments seen for IDegLira and liraglutide were similar. Furthermore, IDegLira resulted in significantly better control of postprandial blood glucose following a standardized mixed meal compared to insulin degludec.



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