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Novo Nordisk Reveals Fresh Data on Xultophy for Diabetes

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Novo Nordisk A/S (NVO) announced data from new analyses of the phase IIIa DUAL studies (DUAL I and DUAL II) on Xultophy. Data showed that after four weeks from the initiation of treatment, Xultophy (a once-daily single injection combination of Tresiba and Victoza) led to more rapid and substantial improvement in glycemic control along with a beneficial weight profile in type II diabetes patients (insulin-naive as well as those treated with insulin previously), compared to the individual administration of Tresiba and Victoza.

At week-4 in the DUAL I study, a higher proportion of patients achieved fasting plasma glucose of ≤7.2 mmol/L under treatment with Xultophy (76%) than patients treated with Tresiba or Victoza (62% each). Moreover, 57% of the Xultophy-treated patients achieved glycated hemoglobin (HbA1c) of less than 7% at week-8 compared to 38% and 47% of those treated with Tresiba and Victoza, respectively.

Additionally, Novo Nordisk said that Xultophy-treated patients were more likely to reach pre-prandial (before meal) and post-prandial (after meal) blood glucose targets compared to either Tresiba or Victoza.

Results from the DUAL II study were consistent with that from the DUAL I study with respect to Xultophy and Tresiba. In the DUAL I study, Xultophy led to significant weight loss in patients compared to Tresiba, however, weight loss with Victoza (1.8 mg) alone was higher than that achieved with Xultophy.

Novo Nordisk presented data from the 52-week DUAL I and the 26-week DUAL II studies at the annual meeting of the European Association for the Study of Diabetes (:EASD).

We note that late last week, Novo Nordisk had received marketing authorization for Xultophy for the treatment of type II diabetes in adults in the EU. EU approval came shortly after approval in Switzerland. The company intends to launch Xultophy in the EU in the first half of 2015.

Meanwhile, Novo Nordisk also presented data from a 26-week, randomized phase IIIb study on Ryzodeg at the EASD meeting. Results showed that twice-daily Ryzodeg (Tresiba/insulin aspart combination) led to successful glycemic control with fewer injections than a basal-bolus regimen consisting of once-daily Tresiba plus 2−4 injections of insulin aspart.

Although the study did not meet its primary endpoint of non-inferiority, patients on both regimens experienced HbA1c reduction. However, patients treated with Ryzodeg experienced a lower rate of overall and nocturnal confirmed hypoglycemic episodes and gained significantly less weight compared to the basal bolus regimen.

Novo Nordisk carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Allergan Inc. (AGN), Abbott Laboratories (ABT) and Johnson & Johnson (JNJ). While Allergan carries a Zacks Rank #1 (Strong Buy), Abbott and Johnson & Johnson hold a Zacks Rank #2 (Buy).

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