New data show Victoza® helped reduce blood sugar when patients with type 2 diabetes switched from sitagliptin or exenatide

Another study shows benefits of adding Levemir® insulin therapy to Victoza®

San Diego, CA (June, 2011) Novo Nordisk will present data from two extension studies at the 71st Annual Scientific Sessions of the American Diabetes Association (ADA) which show that Victoza® (liraglutide [rDNA origin] injection), taken once-daily, in combination with metformin and/or sulfonylurea, helped more patients achieve blood sugar control when compared with other commonly used type 2 diabetes therapies. Although not a weight loss product, the data also demonstrate that patients experienced significant weight loss when switched from sitagliptin to Victoza®[1],[2]

Novo Nordisk will also present data that demonstrate the addition of Levemir® (insulin detemir [rDNA origin] injection) to Victoza® and metformin helped more patients reach and maintain blood sugar targets, with a low frequency of hypoglycaemia and maintained weight loss.[3]

“The results of this study are very encouraging. Not only did Victoza® treatment alone help more than 60% of patients achieve the ADA target for blood sugar control, but also the addition of Levemir® helped many of the remaining patients achieve the ADA target without the increases in hypoglycemia and body weight normally associated with insulin therapy,” said Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer, Novo Nordisk.

Key findings from the studies include:

Switching from exenatide to Victoza® (Poster 1117-P)1

• The majority of patients switched from exenatide to Victoza® experienced further reductions in HbA1C (0.3 – 0.8%)
• In the study, 32% of patients who failed to reach target (HbA1C <7%) with exenatide subsequently reached target with Victoza®with mean 0.8% further reductions in HbA1C

Switching from the DPP-4 inhibitor sitagliptin to Victoza®
(Poster 1119-P)2

• Patients switched from sitagliptin to Victoza®1.2 mg and 1.8 mg experienced further reductions in HbA1C (0.2% and 0.5%, respectively 0.5%)
• More patients treated with Victoza®1.2 mg and 1.8 mg versus sitagliptin (49.2 and 50 vs. 29.5%, respectively) reached the ADA target for blood sugar control (HbA1C<7%)
• Patients switched from sitagliptin to Victoza®1.2 mg and 1.8 mg also experienced significant reductions in body weight (1.6 kg [3.5 lbs] and 2.5 kg [5.5 lbs], respectively)

Adding Levemir® to Victoza® (Oral Presentation 276-P)3

• After completing 12 weeks of treatment with Victoza®and metformin, 61% of patients reached the ADA target for blood sugar control (HbA1C <7%) with mean decreases in HbA1Cof 1.3% and body weight of 4.4 kg (9.7 lbs)
• After the additional 26 weeks, patients randomized to add on Levemir®to Victoza®and metformin had further HbA1Creductions of 0.5%, while HbA1C remained stable in the Victoza® and metformin group
• Furthermore, 43% of patients in the Victoza®, metformin and Levemir® group reached the ADA target for blood sugar control (HbA1C <7%) at 26 weeks vs. an additional 17% in the Victoza® and metformin group
• Patients maintained weight loss after Levemir®was added

About the Studies

Both switch trials were extensions of randomized, open-label studies that compared the efficacy and safety of Victoza®, 1.2 mg and/or 1.8 mg, taken once-daily, to exenatide 10 μg, twice a day or sitagliptin (100mg), all in combination with metformin and/or sulfonylurea.

All patients in the extension arms were treated with once-daily Victoza®1.2 mg or 1.8 mg and metformin and/or sulfonylurea.1,2

To evaluate the safety and efficacy of adding Levemir®to treatment with Victoza®1.8 mg and metformin, a 38-week, randomized, open-label study was conducted. In the initial 12 weeks, patients were treated with Victoza®and metformin. During the following 26 weeks, patients achieving HbA1C< 7% remained in an observational arm while the remaining patients were randomized to Victoza®, metformin and Levemir®or Victoza®and metformin.3

In all studies, for patients treated with Victoza®, the most common gastrointestinal-related adverse events were nausea, which was transient, or short in duration. Low rates of minor hypoglycaemia were also reported.1,2,3

About Victoza®
Victoza® is the first and only human glucagon-like peptide-1 (GLP-1) analogue that is 97% similar to endogenous human GLP-1. Like natural GLP-1, 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 hypoglycaemia.The mechanism of blood sugar lowering also involves a delay in gastric emptying.

Victoza®was approved by the U.S. Food and Drug Administration (FDA) on January 25, 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

As of June 2011, Victoza®has been commercially launched in more than 30 countries globally including the US, Canada, Japan, UK, Japan, Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, the GULF and Malaysia as well as a number of other countries, and will be available in other markets throughout 2011 and 2012.

För mer information, vänligen kontakta:

Sara Jensen, Novo Nordisk Scandinavia AB,
Telefon: 040 38 89 37, 0706-38 89 37
SaJn@novonordisk.com

[1] Buse J et al. Switching from exenatide to liraglutide increases the proportion of patients achieving A1C target. Presented at American Diabetes Association (ADA) June 2011.

[2] Pratley R et al. Switching from the DDP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide further improves glycemic control and weight loss in patients with type 2 diabetes. Presented at American Diabetes Association (ADA) June 2011.

[3] Rosenstock J et al. New Type 2 Diabetes Treatment Paradigm: Sequential Addition of Liraglutide to Metformin and then Basal Insulin Detemir. Presented at American Diabetes Association (ADA) June 2011.