The Significance of the Victoza Product Label Update

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Novo Nordisk’s widely popular GLP-1 analog Victoza made headlines at the beginning of the year when celebrity chef Paula Deen became a spokesperson for the drug.  This month Victoza is in the news again after  Novo Nordisk received approval from the U.S. Food and Drug Administration (FDA) to update the product label for Victoza (liraglutide).  Victoza product label update?  Is that really something significant?  In this case, yes.

The Victoza product label update shows data indicating Victoza’s superior blood sugar control when compared to Merck’s Januvia (sitagliptin) in a study where both products were taken in combination with metformin in adults with type 2 diabetes.  Victoza also showed greater weight reduction when compared to Januvia.  But perhaps more significantly, the update also includes data demonstrating the safety and efficacy of adding basal insulin to Victoza and metformin for the treatment of adults with type 2 diabetes.  I had the opportunity to ask Jason Brett, M.D., Sr. Medical Director, Novo Nordisk, about the Victoza product label update and what it means.

The Victoza product label update indicates that Victoza shows greater efficacy when compared to Januvia. Can you tell us a little bit about the study that proved greater efficacy?  Can you explain the significance of this? 

The Victoza vs. Januvia study was a 26-week randomized, open-label trial in people with type 2 diabetes which found that Victoza demonstrated superior blood sugar control when compared to Januvia as well as greater weight loss (a secondary endpoint). Specifically:

  • Patients treated with 1.2 mg and 1.8 mg of Victoza experienced greater reductions in A1C than those treated with Januvia 100 mg tablets, all in combination with metformin (-1.2% and -1.5% versus -0.9%).
  • Victoza provided greater weight loss versus patients treated with Januvia (2.7 kg [5.94 lbs] and 3.3 kg [7.26 lbs] for 1.2 mg and 1.8 mg respectively, 0.8 kg [1.76 lbs] for Januvia).

These results are significant because Victoza represents an effective option for people with type 2 diabetes who are struggling to lower their blood sugar. The expanded label should provide physicians with greater confidence to prescribe Victoza to patients with type 2 diabetes needing better blood sugar control.

Why is a GLP-1 analog (Victoza) being compared to Januvia, a DPP-4 inhibitor?  Would it be more relevant to have a comparison of Victoza and Byetta?

Although Januvia is not a GLP-1 receptor agonist like Victoza and Byetta, as a DPP-4 inhibitor, it is an incretin-based therapy. Victoza has been compared to Byetta. Head-to-head clinical studies have demonstrated that Victoza provides significantly better A1C reduction than Byetta. Specifically:

  • The LEAD-6 trial, published in 2009 in The Lancet,  found that treatment with Victoza led to a statistically significantly greater drop in A1C of 1.12% compared to 0.79% in the Byetta group, and Victoza was also significantly better than Byetta at lowering fasting plasma glucose -29 mg/dL vs  -11 mg/dL).

Do you expect to see more doctors prescribing Victoza over Januvia based on this label change?

Novo Nordisk cannot speculate on physicians’ prescribing behaviors, but we are excited that the expanded label includes data that both demonstrate that Victoza provides superior blood sugar control when compared to Januvia and that Victoria in combination with basal insulin is a safe and effective treatment for type 2 diabetes.

This expanded label means that a broader range of type 2 diabetes patients may benefit from Victoza.

Victoza showed greater efficacy when compared to Januvia, but what about side effects?  

The 26-week, open label study comparing the efficacy and safety of Victoza with Januvia, found that the adverse reactions reported in equal or greater than 5% of the patients treated with Victoza were nausea (23.9% vs. 4.6%), headache (10.3% vs. 10.0%), diarrhea (9.3% vs. 4.6%) and vomiting (8.7% vs. 4.1%).

Moving onto questions about using Victoza with basal insulin, has Victoza been approved for use only with Levemir, or with other basal insulins as well? 

The FDA has approved the Victoza label to include the approval of basal insulin as an adjunct therapy to Victoza for the treatment of type 2 diabetes.  While the trial on which the Victoza label expansion for use with insulin was conducted with Levemir, the label expansion means that it can be used safely with any basal insulin.

What studies were done to demonstrate the safety of adding basal insulin to Victoza?

The expanded label is based on a randomized, open-label study designed to establish the efficacy and safety of using Victoza in combination with Levemir, a treatment approach that may benefit patients later in the treatment paradigm who are struggling with blood sugar control.  The study found that:

  • After completing 12 weeks of treatment with Victoza and metformin, 50% of patients reached the ADA target for blood sugar control (A1C <7%).
  • After an additional 26 weeks, patients randomized to add on Levemir once a day to their Victoza and metformin regimen had further A1C reductions of -0.5%.
    • Furthermore, 43% of patients in the Victoza, metformin and Levemir group reached the ADA target for blood sugar control (A1C <7%) at 26 weeks vs. an additional 17% in the Victoza and metformin group.
    • Patients did not gain weight after Levemir was added to their treatment regimen.

 

How great is the risk for hypoglycemia when adding basal insulin to Victoza

Based on the results of this trial, the risk of hypoglycemia when adding basal insulin to Victoza appears to be low.   The rate of minor hypoglycemia was 0.29 episodes per patient-year in the patients who added Levemir to metformin and Victoza. This therapeutic strategy of introducing a GLP-1 receptor agonist prior to initiating exogenous basal insulin appears to be a safe approach. Victoza works by stimulating the beta cells to release insulin only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycemia.

Victoza has shown weight loss in patients with type 2 diabetes.  When taken in combination with insulin, do patients still lose weight?

Based on the study of Victoza in combination with Levemir, the results showed that the weight loss seen with Victoza was maintained in the patients who added on Levemir. Although not a weight loss product, other clinical studies have found that Victoza may help patients lose weight.

Victoza and insulin require separate injections, a big drawback for patients.  Is there work being done to create an all-in-one?

As noted on our corporate web site, Novo Nordisk has an ongoing phase 3 clinical development program testing the safety and efficacy of a fixed ratio combination of liraglutide, the active ingredient in Victoza, and insulin degludec, a basal insulin analog.

What sort of changes do you expect to see coming out of this newly approved treatment regimen?  

Novo Nordisk cannot speculate on physicians’ prescribing behaviors, but the expanded label means that more patients struggling with blood sugar control at different stages of the disease may benefit from Victoza.

The label now includes data that demonstrate that Victoza may help patients as an add-on therapy to metformin early in the treatment paradigm as well as later, in combination with other oral agents and basal insulin. We expect that this expanded label will give physicians greater confidence in prescribing Victoza for their patients with type 2 diabetes both at the earlier and later stages of the disease.

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