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

Merck announced the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has authorized Glucophage 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. 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 as well as complications that can lead to serious health issues.

"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," Luciano Rossetti MD, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck said. "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 for the treatment of non-diabetic hyperglycemia, primarily gathered in the large US Diabetes Prevention Program (DPP) and subsequent Diabetes Prevention Program Outcome Study (DPPOS) with Glucophage. This data was complemented by comprehensive safety and efficacy data on Glucophage 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%.

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 SR is now an additional treatment option that may help to slow the deterioration of the blood glucose levels. Treatment with Glucophage 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.

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