The Lancet publishes new data showing that the effectiveness of liraglutida is greater than the sitagliptina for the treatment of type 2 diabetes.

Argentina, April 2010.- the medical journal The Lancet has just published on its web site the results of the first study devoted to compare to liraglutida, an analog of the peptide similar to glucagon-1 (GLP-1) human’s one daily administration, with an inhibitor of DPP – 4 called sitagliptina. Study of 26 weeks, showed that liraglutida produces a significant reduction in hemoglobin glycosylated hemoglobin (HbA1c), plasma glucose in fasting and body weight, compared to sitagliptina, achieving greater or equal overall satisfaction with the tratamiento1.

In addition, significantly more patients achieved target HbA1c, which must be less than 7.0% (according to the American Diabetes Association, ADA, for its acronym in English). Nearly twice the number of participants in the study who received liraglutida reached the target of the ADA, compared to the group that received sitagliptina (56% and 44% in patients treated with liraglutida dose of 1.8 mg and 1.2 mg versus 22 per cent in the group treated with sitagliptina).

The data clearly indicate liraglutida in both dose was more effective than sitagliptina to control the blood glucose in patients with type 2 diabetes, with the additional benefit of the decline in weight ”, explained Dr. Richard Pratly unit transnational medicine for Diabetes and metabolism of the Faculty of Medicine of the University of Vermont in Burlington. having so many patients fighting yet to reduce the level of blood sugar, liraglutida represents an innovative and effective alternative ”.

On the study

The study, to 26 weeks, randomized, parallel and open Group, compared the safety and efficacy of the two recommended doses of liraglutida, of a single daily administration (1.2 mg and 1.8 mg) with sitagliptina, once a day (100 mg), both in combination with metformin. The research, conducted in Europe and North America, assessed 665 patients with diabetes type 2 had no proper control with metformin alone in doses ≥ 1500 mg. daily treatment

Main findings of the estudio:

-liraglutida achieved a higher reduction in the level of HbA1c versus sitagliptina (1.50% and 1.24% respectively for liraglutida at a dose of 1.8 mg and 1.2 mg, and 0.90% to sitagliptina).

-the decline in average GPA was significantly higher with liraglutida (2.14 mmol/l [38.5 mg/dl] and 1.87 mmol/l [33.7 mg/dl] respectively for liraglutida at a dose of 1.8 mg and 1.2 mg)(, and 0.83 mmol/l [15 mg/dl] for sitagliptina).

– liraglutida be obtained a reduction in body weight significantly greater (3.38 kg [7.44 lbs] and 2.86 kg [6.29 lbs] respectively for liraglutida at a dose of 1.8 mg and 1.2 mg, 0.96 kg [2.11 lbs] for sitagliptina).

Within the secondary objectives of the study included the questionnaire of satisfaction the treatment of Diabetes (DTSQ), a tool of validated measurement used in many studies of diabetes in order to determine the degree of satisfaction of the patient with therapy.

Comparing liraglutida with sitagliptina 1.8 mg, the improvement in the overall satisfaction was significantly higher for liraglutida, while satisfaction with both treatments when compared sitagliptina liraglutida 1.2 mg was similar. As regards the perception of desirability of treatment, there was no overall differences between one or another therapy (oral versus injectable medication).

Liraglutida and sitagliptina were well tolerated. Initially recorded rate of nausea in patients treated with doses of 1.8 mg of liraglutida (27%) and 1.2 mg (21%) than in the group who received sitagliptina (5%). However, the nausea caused by liraglutida were transitory: most of the episodes were recorded at the beginning of treatment with few cases of suspension of the same. After a few weeks, the prevalence of nausea in this group was similar to the Group doctors with sitagliptina.

Based on the use of incretinas treatments

Liraglutida and sitagliptina are two anti-diabetic based on the incretinas. Liraglutida is the first similar the peptide similar to glucagon-1 (GLP-1) human’s one daily administration that mimics the natural actions of the hormone GLP-1, while that sitagliptina, a DPP-4 inhibitor acts by blocking the enzyme responsible for the degradation of GLP-1 and other substances.

Both the American Diabetes Association, the European Association for the study of Diabetes2, the American Association of Clinical Endocrinologists and the American College of Endocrinología3, recognize analogues of GLP-1 as therapeutic adjuvants effective agents for patients who do not respond to treatment with metformin and lifestyle changes.

About Liraglutida

Liraglutida is the first similar the peptide similar to glucagon-1 (GLP-1) human with a homology of 97% with natural GLP-1.

Like the natural GLP-1, liraglutida acts by stimulating the beta cells to release insulin only when registers a high level of sugar in the blood. As the mechanism of action depends on the level of glucose, the drug is associated with a low rate of combine. Slow gastric emptying is also involved in the mechanism of decrease in glucose. Liraglutida was approved by the FDA in the United States.UU on January 25, 2010, as adjunctive therapy to diet and exercise to improve control of blood sugar in adult patients with type 2 diabetes.

It was approved by the European Commission in the 27 member countries of the European Union on July 3, 2009. Since March 2010, was also obtained approval regulatory in Japan, Norway, Mexico, Iceland, Switzerland, Lebanon, India, Brazil, Macedonia. The product launched commercially in the United States and United Kingdom, Germany, France and Denmark and in many other European countries. He is expected that during 2010, liraglutida to reach new markets. In August 2009 the corresponding approval application was filed in China. Still awaiting the decision of the authorities regulatory in that country.

Novo Nordisk

Novo Nordisk is a company dedicated to the care of the health and world leader in diabetes care. In addition, Novo Nordisk holds a leading position in areas such as control of hemostasis, treatment with growth hormone and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk has approximately 29000 employees in 81 countries, and sells its products in 179 countries. The actions class B from Novo Nordisk listed on the stock exchanges of Copenhagen and London. Its ADR (American Depositary Receipts) are quoted on the stock exchange of New York under the symbol ‘ NVO ’.

Referencia:

1 RE Pratley, fifth M, T Bailey, Montanya E, Cuddihy R, Filetti S, Thomsen AB Søndergaard RE, Davies M, for the Group of study 1860-LIRA-DPP-4. Liraglutida versus sitagliptina in patients with type 2 diabetes who did not reach adequate metformin glycaemic control: a study at 26 weeks, randomized, open label, parallel group. Lancet 2010; 375 (9724): 1447 – 1456.

2 Nathan DM, Buse JB, MB Davidson, and others. Management of hyperglycemia in patients with Diabetes type 2: consensus Algorítmico for the home and the adjustments of treatment. Statement by the American Diabetes Association and the European Association for the study of Diabetes. Diabetes Care 2009; 32 (1): 193 – 203.

3 Rodbard HW, PS Jellinger, JA Davidson, and others. Conclusions of the American Association of clinical endocrinology / Panel of consensus of the College American of Endocrinology on M. type 2 Diabetes: glycaemic Control algorithm. Endocrine Practice 2009; 15 (6): September/October.

Victoza ® (liraglutida) are registered trademarks of Novo Nordisk A/S
Januvia ® (sitagliptina) is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.