In addition, significantly more patients achieved the HbA1c targets of <7Â·0% (American Diabetes Association [ADA]). Nearly twice as many study participants on Victoza® reached the ADA goal compared to the Januvia® group (56% and 44% in the 1.8 mg and 1.2 mg Victoza® groups versus 22% in the Januvia® group).
"These data clearly show that Victoza® at both doses was more effective than Januvia® at achieving blood sugar control in people with type 2 diabetes with the benefit of weight loss," said Dr Richard Pratley, of the Diabetes and Metabolism Translational Medicine Unit, University of Vermont College of Medicine, Burlington. "With so many patients still struggling to lower their blood sugar, Victoza® represents an effective new option."
About the study
The study was a 26-week, randomised, parallel-group, open-label trial comparing 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. It was conducted in Europe and North America in 665 people with type 2 diabetes who were not adequately controlled on daily treatment with =1,500 mg metformin alone.
Major findings from the study include:
- Victoza® provided superior reductions in HbA1c versus Januvia® (1.50% and 1.24% respectively for Victoza® 1.8 mg and 1.2 mg, 0.90% for Januvia®).
- Mean decreases in FPG were significantly greater with Victoza® (2.14 mmol/l [38.5 mg/dl] and 1.87 mmol/l [33.7 mg/dl] respectively for Victoza® 1.8 mg and 1.2 mg, 0.83 mmol/l [15 mg/dl] for Januvia®).
- Victoza® resulted in significantly greater reductions in body weight (3.38 kg [7.44 lbs] and 2.86 kg [6.29 lbs] respectively for Victoza® 1.8 mg and 1.2 mg, 0.96 kg [2.11 lbs] for Januvia®).
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 Januvia®, and similar between Victoza® 1.2 mg and 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® 1.8 mg (27%) and 1.2 mg (21%) than 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®.
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 American Diabetes Association 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 effective add-on treatment for patients who are not responding to metformin and lifestyle changes alone.
Victoza® is the only human GLP-1 analogue; it has 97% homology to natural 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 been approved by the European Commission in all 27 European Union member states on 3 July 2009. As of March 2010, approval has also been granted by the regulatory authorities in Japan, Norway, Mexico, Iceland, Switzerland, Lebanon, India, Macedonia and Brazil. Victoza® has already been commercially launched in the US as well as the UK, Germany, France and Denmark and a number of other European countries; it 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.
For more information on Victoza®, visit novonordisk.com.
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.
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2. Nathan DM, Buse JB, Davidson MB, et al. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. A Consensus Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32(1):193â203.
3. Rodbard HW, Jellinger PS, Davidson JA, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology Consensus Panel on Type 2 Diabetes Mellitus: An Algorithm for Glycemic Control. Endocrine Practice 2009; 15(6): September/October.
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.
Source: Diabetes PubMed