Diabetes drug Victoza (liraglutide [rDNA] injection) has been shown to be superior to Januvia (sitagliptin) in achieving body weight reduction and blood sugar control, Novo Nordisk has announced. The drug’s label in the USA has been updated, demonstrating its superior effectiveness when compared to Januvia, as well as approval by the Food and Drug Administration for combination treatment for patients with diabetes type II (Vectoza in combination with basal insulin).

Novo Nordisk informs that a label update also explains about the safety and efficacy of adding basal insulin to Victoza and metformin for diabetes type II therapy.

The FDA examined data from two large, randomized, open-label clinical trials in adult patients with diabetes type II.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said:

“The data from these studies further demonstrate the strong clinical profile and the value of Victoza in the treatment of type 2 diabetes.”

This open-label, randomized human study, which lasted 26 weeks, was carried out to determine and compare:

    • Metformin plus Victoza 1.2 mg and 1.8mg, against
    • Merformins plus Januvia 100 mg tablets

The researchers found that the participants on..:

    • 1.2 mg of Victoza experienced a 1.2% reduction in HbA1C
    • 1.8 mg of Victoza experienced a 1.5% reduction in HbA1C
    • 100 mg tablets of Januvia experienced a 0.9% reduction in HbA1C
    • 1.2 mg of Victoza achieved a 2.7 kg (5.94 lbs) weight loss reduction
    • 1.8 mg of Victoza achieved a 3.3 kg (7.26 lbs) weight loss reduction
  • 100 mg tablets of Januvia achieved a 0.8 kg (1.76 lbs) weight loss reduction

This open-label, randomized human study, which also lasted 26 weeks, was carried out to determine how safe and effective adding insulin detemir (Levemir) once daily to Victoza 1.8 mg plus metformin.

Initially, participants received Victoza plus metformin for 12 weeks. 50% of them reached HbA1C<7% (the ADA target for blood glucose control). During the next 26 weeks, those who had achieved HbA1C <7% during the initial 12 weeks stayed on the same treatment regimen (the observational group), the rest were selected randomly into two groups:

    • Levemir was added to the existing Victoza plus metforming treatment (plus Levemir group)
  • Nothing was added to the existing Victoza plus metforming treatment (plus nothing group)

At the end of the 26 weeks, those in the plus Levemir group achieved a further 0.5% reduction in HbA1C, while the participants in the plus nothing group’s HbA1C remained stable.

At the end of the 26-week period:

    • 43% more of those in the plus Levemir group achieved a HbA1C <7% level, the ADA target for blood sugar control
    • 17% more of those in the plus nothing group achieved the same ADA target for blood sugar control
  • None of the plus Levemir group participants gained weight

The incidence or reported adverse events was similar among all three groups (randomized treatment groups and non-randomized treatment group).

Victoza (liraglutide [rDNA origin] injection) is the first and only human glucagon-like peptide-1 (GLP-1) that is 97% similar to GLP-1 that is produced from within the human body. Victoza stimulates insulin-release by the beta cells only when blood glucose levels are elevated. Hypoglycemia rates are low among those taking Victoza.

Written by Christian Nordqvist