Orlando, FL – Poster 16LB – Late-breaking Novo Nordisk extension data presented today at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily Victoza^® in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose (FPG) than Januvia^® plus metformin at 52 weeks.

“What is so encouraging about these data is that Victoza^® at both doses was more effective than Januvia^® at achieving blood sugar control in people with type 2 diabetes over a period of one year,” said Dr Richard Pratley, of the Diabetes and Metabolism Translational Medicine Unit, University of Vermont College of Medicine, Burlington. “Although Victoza^® is not indicated for the management of obesity, the study showed that Victoza^® provided greater weight loss than Januvia^®, which is a benefit for those patients with type 2 diabetes struggling to maintain a healthy weight.”

In addition, significantly more patients treated with Victoza^® achieved the ADA recommended A1c target of <7.0%. Nearly twice as many study participants on Victoza^® reached the ADA goal compared to the Januvia^® group (50% and 63% in the 1.2 mg and 1.8 mg Victoza^® groups versus 27% in the Januvia^® group).

About the study

This study extension compared the safety and efficacy of the two recommended doses of once-daily Victoza^® (1.2 mg and 1.8 mg) with once-daily Januvia^® (100 mg), all added to metformin. After the initial 26-week randomised, double-blind, open-label trial, patients were enrolled in this 26-week extension. The trial was conducted in Europe and North America in 497 people with type 2 diabetes who were not adequately controlled on metformin alone.

Secondary endpoints included the Diabetes Treatment Satisfaction Questionnaire (DTSQ), a validated measure used in many diabetes trials to measure the change in treatment satisfaction. Improvement in overall treatment satisfaction was significantly greater with Victoza^® 1.8 mg than with Januvia^®. No overall differences in the perceived convenience of treatment (oral versus injection) were reported.

Both Victoza^® and Januvia^® were well tolerated. Nausea initially occurred at higher rates with Victoza^® 1.2 mg (21%) and 1.8 mg (27%) than with Januvia^® (5%). However, nausea with Victoza^® was transient – most episodes occurred early with few withdrawals; by later weeks, the prevalence of nausea was similar to that of Januvia^® with <2% reporting nausea in weeks 27–52.

Incretin-based diabetes treatments

Victoza^® and Januvia^® are both incretin-based diabetes therapies. Victoza^® is the first once-daily human GLP-1 analogue that mimics the activity of the naturally-occurring hormone, GLP-1, while Januvia^®, a DPP-4 inhibitor, blocks the enzyme responsible for the breakdown of GLP-1 and other substances.

Consensus statements from the ADA and the European Association for the Study of Diabetes, and the American Association of Clinical Endocrinologists, and the American College of Endocrinology recognise GLP-1 analogues as an effective add-on treatment for patients who are not responding to metformin and lifestyle changes alone.

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