The world’s largest diabetes company and leaders in diabetes research, Novo Nordisk, has launched the first co-formulation of a short-acting and a true long-acting insulin analogue in South Africa.

 Worldwide, diabetes is a leading cause of cardiovascular disease, blindness, kidney failure and lower limb amputation.

According to VP and General Manager at Novo Nordisk South Africa, Dr Timmy Kedijang, there are 2.7 million South Africans living with diabetes, of which 60% to 80% will die before the age of 60. Furthermore, diabetes accounts for almost one out of every three deaths among the economically active age group of 30 to 40 years.

Type 2 diabetes is the most common form of the disease,  but 50% of those who have it aren’t even diagnosed, and out of those that are, only 50% have access to care, and of those only 50% achieve the desired outcome of glucose control,” said Dr Kedijang.

Type 2 diabetes occurs when the body doesn’t produce enough insulin, or when it cannot respond adequately to the insulin that it does produce. In the absence of insulin or its effects, glucose accumulates in the blood, starving the cells of energy, and also causing damage to blood vessels and nerves.

Careful control of blood glucose can help prevent or delay the potentially devastating consequences of untreated diabetes. Initially this may be adequately achieved with lifestyle change and oral medication, but because of the progressive nature of the disease, most people with type 2 diabetes will eventually require insulin.

During a media briefing at the launch of the new co-formulation insulin, Primary Care Medical Advisor Diabetes UK & Clinical Lead for Diabetes Royal College of General Practitioners (RCGP), Dr Stephen Lawrence, explained how the goal of insulin therapy is to mimic the body’s natural insulin secretion, but this has proved to be challenging.

“In a healthy individual, the pancreas produces a small, but variable amount of insulin throughout the day, referred to as ‘basal’ insulin secretion. After meals, when glucose levels are very high, there is a short-acting surge of insulin production, which peaks at around 45-60 minutes, followed by a return to baseline within 2 to 3 hours. In people with type 2 diabetes, low levels of insulin mean that not only will blood glucose increase dramatically after meals, it also remains high in between meals,” said Dr Lawrence.

Dr Lawrence added that until recently, conventional insulin formulations have been unable to accurately replicate normal insulin secretion. The duration of action may be unpredictable and variable from dose to dose and in different people, meaning that glucose control is inconsistent and there is a risk of glucose levels falling dangerously low (hypoglycaemia).

“Over the past decade, long-acting insulin analogues with improved time-action profiles that reduce this variability have been developed to mimic basal insulin secretion more closely. However, to provide effective glucose control, they need to be combined with short-acting insulin to control glucose after meals, which must be administered separately, requiring multiple daily injections. Together with the fear of hypoglycaemia, this adds to perceived treatment burden and reduces the likelihood that people with diabetes will persevere with their treatment,” said Dr Lawrence.

Because of the unique formulation of the new co-formulation insulin, consisting of short-acting and true long-acting insulin, it provides an even profile of basal insulin over 24 hours and mealtime insulin in a single injection delivered from one pen device.

 In contrast to currently available premixed insulins, which are a combination of short-acting insulin and the same insulin modified to provide an intermediate-acting component, this new co-formulation improves fasting and mealtime glucose control and reduces the risk of hypoglycaemia. Dosing is highly flexible to allow for different individual insulin requirements and eliminates the risk of stacking.

According to Dr Kedijang, the co-formulation represents new hope for people with type 2 diabetes. “It may help them and healthcare professionals overcome the barriers to intensifying treatment, potentially enabling more people to achieve their glucose targets with a lower risk of hypoglycaemia, flexible dose times and fewer injections.”

While the new co-formulation insulin has been officially launched in South Africa, it is still awaiting final NDoH pricing approval.

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