Merck's Glucophage(R) SR Receives Label Extension for Patients at High Risk of Type 2 Diabetes in the UK

PR68606

DARMSTADT, Germany, May 18, 2017 /PRNewswire=KYODO JBN/--

- Not intended for U.S. based media

Glucophage(R) SR offers UK healthcare professionals the first licensed

treatment option for overweight adult patients at high risk of progression to

type 2 diabetes, after failure of intensive lifestyle changes

Non-diabetic hyperglycemia, also known as impaired glucose regulation or

pre-diabetes[1], was estimated in 2009 to affect around seven million adults in

the UK[2] and is predicted to significantly increase in the coming years[3]

Merck, a leading science and technology company, today announced that the

Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has

authorized Glucophage(R) SR (sustained release formulation; metformin), for the

reduction in the risk or delay of the onset of type 2 diabetes in adult,

overweight patients with impaired glucose tolerance (IGT) and/or impaired

fasting glucose (IFG), and/or increased glycated hemoglobin (HbA1c), when

intensive lifestyle changes for 3 to 6 months have failed. This condition is

referred to by a variety of names in medical guidelines, i.e. as non-diabetic

hyperglycemia, as impaired glucose regulation, or as pre-diabetes.[1],[4]-[7]

Merck has already received authorization for this indication in several

countries around the world. Through earlier intervention, patients can reduce

their risk of developing type 2 diabetes[8] as well as complications that can

lead to serious health issues.[5]

"We are pleased that patients at risk of diabetes in the UK now have a

medicinal treatment option to help them delay the onset of diabetes, when

intensive lifestyle changes alone are not enough to work against the

progression to type 2 diabetes," said Luciano Rossetti MD, Executive Vice

President, Global Head of Research & Development at the biopharma business of

Merck: "According to WHO, diabetes is considered a global pandemic and we are

committed to helping slow the rapidly growing incidence. This is an important

achievement as it can help play a role in reducing the burden of type 2

diabetes for patients."

The authorization is based on clinical data on the efficacy of Glucophage(R)

for the treatment of non-diabetic hyperglycemia, primarily gathered in the

large US Diabetes Prevention Program (DPP)[8] and subsequent Diabetes

Prevention Program Outcome Study (DPPOS)[9]-[11] with Glucophage(R). This data

was complemented by comprehensive safety and efficacy data on Glucophage(R)

collected since its first use in patients in 1957.

Non-diabetic hyperglycemia is triggered by insulin resistance, that causes

cells to be unable to effectively utilize insulin, which is needed to get the

glucose inside the cells and to stabilize blood glucose levels. This is also

called impaired glucose tolerance (IGT). As a response, more insulin may be

produced, which may again lose efficacy over time. Eventually, blood glucose

levels in the body rise to higher than normal values even between meals, which

is called impaired fasting glucose (IFG). Elevated blood glucose levels are

also often measured as an average over time through HbA1c. The corresponding

lab values for diagnosis of non-diabetic hyperglycemia as per UK's National

Institute for Health and Care Excellence (NICE) guidelines, are fasting glucose

between 100 and 125 mg/dl, and/or 140 to 199mg/dl in a glucose tolerance test,

and/or HbA1c between 6.0 and 6.4%.[1]

From this stage of non-diabetic hyperglycemia, the disease may then further

slowly progress to overt type 2 diabetes. Intensive lifestyle changes will be

used as a first counter action. If the patient is still at high risk of

progression to type 2 diabetes after 3 to 6 months with worsening glycemic

control despite intensive lifestyle measures, Glucophage(R) SR is now an

additional treatment option that may help to slow the deterioration of the

blood glucose levels. Treatment with Glucophage(R) SR must be based on a risk

score incorporating appropriate measures of glycemic control and including

evidence of high cardiovascular risk. A benefit in the reduction of risk or

delay of the onset of type 2 diabetes has not yet been established in patients

75 years and older.

About Glucophage(R)

Glucophage(R) (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(R) may be given alone or with oral antidiabetic agents, or with

insulin. The most commonly reported side effects with Glucophage(R) SR are

gastro-intestinal disturbances that may occur during treatment initiation and

resolve spontaneously in most cases.

The Glucophage(R) product portfolio comprises: Glucophage(R) IR (immediate

release formulation) and Glucophage(R) SR (sustained release formulation).

Outside of the UK, Glucophage(R) SR is known as Glucophage(R) XR (extended

release). In addition, Merck produces Glucovance(R) a fixed dose combination of

metformin and glibenclamide.

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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 2016, Merck generated sales of EUR 15.0 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 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.

References

1. NICE guideline ph38: Type 2 diabetes: prevention in people at high risk.

Published 12 July 2012. Available at:

https://www.nice.org.uk/guidance/ph38/chapter/8-glossary#pre-diabetes

2. Diabetes UK. (2009). Preventing the Type 2 diabetes epidemic: October 2009.

Available at:

https://www.diabetes.org.uk/Documents/Reports/PrediabetesPreventingtheType2diabetesepidemicOct2009report.pdf

3. IDF (International Diabetes Federation). IDF Diabetes Atlas, seventh edition

2015.

4. ADA (American Diabetes Association). Standards of Medical Care in Diabetes.

Diabetes Care 2013; 36(1):S11-66

5. ESC (European Society of Cardiology). Diabetes, Prediabetes and

Cardiovascular Diseases. Available at:

http://www.escardio.org/guidelines-surveys/esc-guidelines/Pages/ diabetes.aspx

6. Ryden L, Grant PJ, Anker SD et al. ESC Guidelines on diabetes, prediabetes,

and cardiovascular diseases developed in collaboration with the EASD - Summary.

Eur Heart J 2013; 34:3035-3087

7. IDF (International Diabetes Federation). (2012). Clinical Guidelines Task

Force: Global guideline for the management of type 2 diabetes.

8. DPP Research Group. Reduction in the Incidence of Type 2 Diabetes with

Lifestyle Intervention or Metformin. N Engl J Med 2002; 346:393-403

9. DPP Research Group. 10-year follow-up of diabetes incidence and weight loss

in the Diabetes Prevention Program Outcomes Study. Lancet 2009; 374:1677-1686

10. Perreault L, Pan Q, Mather KJ et al. Effect of regression from prediabetes

to normal glucose regulation on long-term reduction in diabetes risk: results

from the Diabetes Prevention Program Outcomes Study. Lancet 2012;

379(9833):2243-2251

11. DPP Research Group. Long-term Effects of Lifestyle Intervention or

Metformin on Diabetes Development and Microvascular Complications: the DPP

Outcomes Study. The Lancet Diabetes and Endocrinology 2015 3(11):866-875

Contact:

Bettina Frank

+49-6151-72-4660

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SOURCE: Merck