Key findings from the study include:
- Patients treated with 1.2 mg and 1.8 mg of Victoza® experienced greater reductions in A1c than those treated with Januvia® 100 mg (-1.3% and -1.5% versus -0.9%).
- Victoza® provided greater weight loss versus patients treated with Januvia® (2.8 kg [6.16 lbs] and 3.7 kg [8.14 lbs] for 1.2 mg and 1.8 mg respectively, 1.2 kg [2.64 lbs] for Januvia®).
- Victoza® provided greater change from baseline FPG readings than those treated with Januvia® (-1.7 mmol/l and -2.0 mmol/l for 1.2 mg and 1.8 mg respectively, versus -0.6 mmol/l).
- Patients treated with Victoza® 1.8 mg reported significantly greater treatment satisfaction than those treated with Januvia®.1
"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 â 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 27â52. 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.
Victoza® is the first and only human GLP-1 analogue that is 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® (liraglutide) 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 hypoglycaemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.
Victoza® was approved by the US Food and Drug Administration (FDA) on 25 January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
Victoza® has also been approved by the European Commission in all 27 European Union member states. As of June 2010, approval has also been granted by the regulatory authorities in Japan, Norway, Mexico, Iceland, Lebanon, Russia, Argentina, India, Brazil, Canada and Switzerland. Victoza® has already been commercially launched in the US, UK, Germany, France and Denmark as well as a number of other European countries and will be available in other markets throughout 2010. A New Drug Application was also submitted for approval in China in August 2009. A regulatory decision is pending.
About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.com.
Victoza® is a registered trademark of Novo Nordisk A/S
Januvia® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.