Glucophage® is now approved for patients with prediabetes

  • Glucophage® (metformin), medication for treatment of diabetes mellitus, is the only metformin in Russia approved for patients with prediabetes.
  • Prediabetes, a condition preceding type 2 diabetes, is common among 10-16% of the population in developed nations¹.
  • Numerous clinical studies confirmed the effectiveness of metformin as a treatment to prevent type 2 diabetes and its complications in addition to life style changes.

 

Merck, a leading science and technology company, announced that new indication for Glucophage® (metformin) was registered in Russia lately. It has become the only metformin in Russia approved for prevention of type 2 diabetes among patients with prediabetes with additional risk factors of development of type 2 diabetes who failed to achieve adequate glycemic control through lifestyle change alone. It is a big step forward in fighting the epidemics of type 2 diabetes in this country.

Rogier Janssens, Head of Russia and CIS Merck Biopharma, says: “Registration of a new indication for Glucophage® provides an opportunity to prevent or delay the development of type 2 diabetes among patients with prediabetes. This, will lead to saving peoples’ lives and cutting the government costs for treatment of the complications of the disease. Russia is not the first country to authorize such indication for Glucophage®. Previously, the indication was included in the drug’s label in countries such as Hungary, Mexico, Poland and Turkey. We are working for the benefit of the patients and the well-being of the nation, and we are happy that the Russian patients with prediabetes can benefit from this treatment.”

In 2015, Merck localized the production of Glucophage® in Russia, at NANOLEK facility in Kirov region. To date, 2.2 million packages of this vital drug have been produced. A shift to full production cycle is planned for the second half of 2016. The planned volume of production is about 400 million tablets of Glucophage®, which will allow Merck to fully meet the needs of the Russian pharmaceutical market in this drug. Production of this drug is effected in full compliance with GMP requirements, the quality is identical to the one produced in other parts of Europe and is under constant supervision by Merck.

According to International Diabetes Federation (IDF), by 2040 the number of patients diagnosed with diabetes mellitus will reach 642 million people globally². The term “prediabetes” describes a change in carbohydrate metabolism that precedes type 2 diabetes. The term is used to emphasize high risk of future development of the disease and an increased risk for microvascular and macrovascular complications. Prediabetes is characterized with manifestation of one of the following states: impaired fasting glycemia (blood glucose level) or impaired glucose tolerance or impaired HbA1c. Early diagnostics and correction of such condition enables to avoid or delay the development of type 2 diabetes and its complications³.

Various epidemiological studies show that the prevalence rate of prediabetes is from 10% to 16% of the adult population in developed nations¹. Oftentimes, prediabetes develops without symptoms and is discovered accidentally. Each year, 4-9% of patients with prediabetes develop type 2 diabetes1. In order to examine the prevalence of diabetes the first national epidemiological study NATION4was conducted in 63 Russian regions. The results show that 19.3% of 26.620 people examined have borderline glycated hemoglobin level, which translates to approx. 20.7 million people with prediabetes if the results are extrapolated to the whole adult population of Russia. It clearly indicates the high incidence of prediabetes and the severity of the problem.

Lifestyle correction is essential for treatment of prediabetes: healthy nutrition, increased physical activity, abandoning bad habits, following sleep-wake routine and weight loss in case of obesity. However, in some cases these measures prove insufficient, and a medical treatment is required.

Clinical studies5,6 have confirmed the effectiveness of Glucophage® treatment during prediabetes stage. Thus, Diabetes Prevention Program research shows significant reduction of risk of the development of type 2 diabetes (by 31%) from taking Glucophage® (1,700 mg per day) as compared to placebo7. The medication is most effective among young patients with massive obesity.

 

References

  1. Ванюков Д.А. Предиабет: диагностика и лечение. Трудный пациент. Февраль 2007.
  2. IDF Atlas 20153 М.Ф.Калашникова и др. Предиабет: современные критерии диагностики и лечения. Вестник репродуктивного здоровья март 2009.
  3. Калашникова М.Ф. и др. Предиабет: современные критерии диагностики и лечения. Вестник репродуктивного здоровья март 2009.
  4. Dedov I.I. et al. The prevalence of type 2 diabetes mellitus in the adult population of Russia (NATION study). Diabetes mellitus 2016.
  5. DPP Research Group. N Engl J Med 2002;346:393–403 2. DPPOS. Lancet Diabetes Endocrinol, published online September 14, 2015. http://dx.doi.org/10.1016/S2213-8587(15)00291-0
  6. DPP Research Group. Lancet 2009;374:1677–1686; 2. Perreault L, et al. Lancet 2012;379(9833):2243–2251
  7. Body size and shape changes and the risk of diabetes in the Diabetes Prevention Program (DPP). Fujimoto W.Y., Jablonski K.A., Bray G.A., Kriska A., Barrett-Connor E., Haffner S., Hanson R., Hill J.O., Hubbard V., Stamm E. and Pi-Sunyer F.X. Diabetes. 0: db07-0009v1-0 (2007).

 

About Glucophage® (metformin)

Glucophage® (metformin hydrochloride) is a prescription-only medicine indicated for the treatment of type 2 diabetes mellitus particularly in overweight patients when diet and exercise alone have failed. In adults, Glucophage® may be given alone or with oral antidiabetic agents, or with insulin. In children from 10 years old and adolescents, Glucophage® may be given alone or with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with Glucophage® as first-line therapy after diet failure. The most commonly reported side effects with Glucophage® are gastro-intestinal disturbances that may occur during treatment initiation and resolve spontaneously in most cases. Glucophage® is contraindicated in patients with a GFR below 45ml/min.

Glucophage is also approved now in prediabetes in patients with additional risk factors of development of type 2 diabetes who failed to achieve adequate glycaemic control through lifestyle change
The Glucophage® range comprises: Glucophage® IR (immediate release) and Glucophage® XR (extended release). In addition, Merck produces Glucovance® a fixed dose combination of metformin and glibenclamide.

About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of € 12.85 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.