Dr Angela Murphy explains why people are using Ozempic off-label for weight loss resulting in a shortage for people with diabetes who need it for glucose control, not only in SA but around the world.

The twin pandemics of obesity and Type 2 diabetes have created a need to find a common management pathway. A healthy lifestyle is essential; no medication will override a poor diet or lack of exercise. However, for many people living with diabetes, medications are needed to control blood glucose levels and lose meaningful weight.

Definition recap

Diabetes – diagnosed when fasting blood glucose is ≥7.0mmol/L, and/or two-hour post glucose drink test is ≥ 11.1mmol/L and/or HbA1c >6.5%

Obesity – body mass index (BMI) which is calculated by dividing height squared into weight: > 30kg/m2 = obese and                                                                                                                                             25-30kg/m2 is overweight

It’s important to measure waist circumference in patients to ascertain the degree of visceral fat. It’s this fat which causes most of the metabolic complications, especially diabetes.

A novel hormone pathway

The incretin hormones are produced in the cells lining the small intestine in response to digested food entering there. These hormones alert the pancreas to make insulin to control blood glucose at mealtimes. This system has been found to be sluggish in Type 2 diabetes, so medications were developed to improved incretin hormone levels.

There are two main incretin hormones in the human body: glucagon-like peptide 1 (GLP-1) and gluco-inhibitory peptide (GIP).  The medications produced to increase GLP-1 levels are called GLP-1 receptor agonists and have made a significant impact on the treatment of both diabetes and obesity. They do this by:

1. Stimulating the pancreas to increase insulin.
2. Blocking the liver from producing glucose.
3. Directly inhibiting the appetite centre in the brain.
4. Decreasing how quickly the stomach empties which means a person feels full for longer.

In addition, some of the GLP-1 medications have been shown to protect the heart.

The GLP-1 receptor agonist medications

Most GLP-1 receptor agonists are given as a subcutaneous injection as they are rapidly destroyed in stomach acid. However, oral forms are now available overseas.

GLP-1 receptor agonists registered in South Africa for diabetes

• Byetta (exenatide) – This was the first GLP-1 receptor agonist in South Africa. It’s given as a twice daily injection within 60 minutes of breakfast and dinner. It’s effective in lowering blood glucose after meals but doesn’t have much effect on weight.
• Victoza (liraglutide) – This is given as a daily injection starting at a dose of 0.6mg daily and increasing to 1.8mg daily and has shown significant improvement in weight loss.
• Trulicity (dulaglutide) – This is a weekly injection given with a single-use device so the needle isn’t visible. It comes in one dose of 1.5mg weekly and has excellent glucose lowering properties but doesn’t result in significant weight loss.
• Ozempic (semaglutide) – This is a weekly injection where the dose is titrated from 0.25mg to 1mg depending on the blood glucose levels. Ozempic also lowers blood glucose levels effectively and has shown good weight loss.

GLP-1 receptor agonists not available in South Africa

• Rybelsus (oral semaglutide) – This is the only oral GLP-1 receptor agonist available as a daily pill either in a 7mg or 14mg dose.
• Mounjaro (tirazepatide) – Strictly speaking this is a dual incretin agent (it acts on both GLP-1 and GIP receptors). Clinical trials have shown it to be superior to all the above GLP-receptor agonists in controlling blood glucose and weight loss in patients with Type 2 diabetes.

GLP1-receptor agonist medications and weight loss

Registered in SA

Only one GLP-1 RA is registered in South Africa for weight loss:

Saxenda (liraglutide) – You will note it’s the same product as Victoza but when used for weight loss it’s marketed in larger doses and under a different name.

Clinical trials showed that meaningful weight loss was achieved at a dose of 3mg daily, significantly higher than the doses used to treat diabetes. The best results were achieved in subjects who had already lost at least 5% weight on calorie restriction before starting Saxenda. Then over the course of 56 weeks they lost a further 6kg of body weight.

Not registered in SA

Ozempic (semaglutide) is not registered for weight loss in South Africa. The molecule, semaglutide, is registered overseas for weight loss under the name Wegovy.

As has been seen with liraglutide, Ozempic needs to be given in higher doses for weight loss – up to 2.4mg weekly. The STEP clinical trials demonstrated weight loss of approximately 10 – 15%. STEP 4 particularly looked at what happened after the medication was stopped: after using semaglutide 2.4mg weekly for 20 weeks, subjects had treatment discontinued and had regained 6kg by the end of the trial. This emphasises the chronic nature of obesity management.

People are using Ozempic off-label for weight loss, including celebrities who posted on social media of its effectiveness. This, unfortunately, resulted in a run on the drug and stocks plummeted. The tragedy of this is that people with diabetes using Ozempic for glucose control have struggled to get their supply; a problem both in South Africa and around the world.

Mounjero is not yet registered for weight loss but there is no doubt that it will be (possibly under a different trade name) as clinical trial results show subjects are shedding up to 20% of body weight. This is the most effective weight loss medication to date.

GLP-1 receptor agonists side effects

The most common side effects are gastro-intestinal: nausea, vomiting, diarrhoea, abdominal cramps, and heartburn. These side effects can be reduced with the following measures:

1. Eat small portions.
2. Avoid fatty meals.
3. Chew food thoroughly.

These medications should not cause hypoglycaemia (low blood glucose) but if they are being added to insulin or other oral diabetes medications that can cause hypoglycaemia (sulphonylureas), low blood glucose levels must be watched for. The other medications can be decreased in dose.

A history of pancreatitis is a contra-indication to using these medications and they are not registered for use in pregnancy or when breastfeeding.

If a person has a history of thyroid cancer, they may be advised not to use GLP-1 receptor agonists. However, it’s important to understand that this risk is theoretical based on rat studies. No case of thyroid cancer due to these medications has been described in humans.

Medical aid reimbursement

Many medical aids do reimburse for this group of medications for people living with diabetes. Certain criteria must be met, for example, glucose levels not well-controlled on other medications and an increased weight.

Your doctor will usually have to motivate to get cover under chronic benefits. Note: medical aids don’t recognise obesity as a chronic condition and will not cover medication to treat it.

The cost of Saxenda at a dose of 3mg daily is over R4 000 per month. This is a significant financial commitment. It’s vital to remember that Saxenda’s effects will be lost if the medication is stopped. Treating obesity should be approached in the same way as treating diabetes or hypertension: as a chronic condition.

The challenge

Managing the combination of obesity, diabetes and pre-diabetes can be frustrating. A balanced lifestyle is the cornerstone to this, but it’s difficult for people to constantly be told to eat less and move more and still see no meaningful changes.

There is a great need for a pharmacological intervention and the GLP-1 receptor agonists are a step in the right direction. However, their use is restricted by possible side effects, cost, and the need for them to be used as ongoing treatment.

It’s my opinion that the reason we fail to achieve meaningful and sustained weight loss is that there is a tendency to look for a cure for overweight or obesity. It’s a concern that many people will use GLP-1 receptor agonist medications for short periods and once they achieve some weight loss, or if lucky even their goal weight, they will stop. After some months weight regain will start and the perception will be that these drugs are no better than any weight loss agent that has come before.

The future

There is no doubt that the GLP-1 receptor agonists offer the best medical intervention for overweight and obesity to date. If they are used as part of a holistic approach to a healthy lifestyle then significant, sustained weight loss may be achieved. It remains to be seen if funders will reimburse for their use on chronic benefits and whether people will use them as a regular, chronic prescription drug.

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Diabetes nurse educator, Kate Bristow, shares effective tips to manage diabetes when you have flu.

Winter season is here and with it an increase in the incidence of colds and flu. For someone with diabetes, flu can be more than just an irritation as it makes managing blood glucose levels more challenging.

What is the difference between a cold and flu?

A cold is an upper respiratory tract infection. Common symptoms include: starting with a sore throat, followed by a runny nose and some congestion and then a cough. Fever is uncommon in adults.

Colds and flu do share many symptoms, but an infection with influenza also manifests with higher temperatures, body aches, and cold sweats or shivers. This may be a good way to tell the two apart.

Flu symptoms are normally more severe and come on quickly. Both are caused by viruses and generally need to run their course. If they progress to a bacterial infection, then an antibiotic may be necessary. Stay in touch with your healthcare team when you are unwell.

How best can you manage your diabetes when you have a cold or flu?

When you are sick your body will make more glucose to give itself the energy to fight the infection, and to add to this you may make more of the stress hormone cortisol. Cortisol makes you more insulin resistant. This means that when you are sick you need more insulin and not less.

So, in effect what happens when you are sick is that your liver will produce more glucose and you will be more insulin resistant. It’s a double whammy for your body and your glucose levels. You will probably be thirstier and pass more urine in this case and the cells in the body will start looking for other ways to get energy.

The lack of fuel into the cells means that they will start looking for other energy sources and sometimes the body starts to break down fat to provide this. Fat is converted into ketones by the liver. Ketones are toxic to the body and can be very dangerous.

Look out for signs such as stomach aches, nausea and vomiting along with high blood glucose levels. This is called ketoacidosis and it’s important that you have an individualised sick day management plan that you have discussed with your healthcare team.

If you are not taking insulin

It’s still important to track your glucose levels even if you are not using insulin. Follow the guidance below:

• Test your blood glucose more regularly; this includes during the night and 2 to 4 hourly during the day depending on your numbers.
• Drink more water. You may be thirstier than normal. If you are feeling nauseous then sip steadily rather than gulping it down. It’s not necessary to eat if you are feeling nauseous. But do ensure you stay hydrated.
• Take your medication as prescribed. Your doctor may ask you to stop certain oral diabetes medications when you are sick.

If you are taking insulin

• Do not stop taking your insulin. You may need more rather than less due to the higher glucose levels.
• If you are taking insulin to manage your diabetes and your glucose levels are high, check for ketones – see the symptoms of ketoacidosis below.

SIGNS AND SYMPTOMS OF KETOACIDOSIS (DKA)

High blood sugar levels – you will be thirsty and may urinate more often.  This leads to dehydration and further stress on your body.

Possible signs of ketone build-up:

• Nausea and stomach-ache and eventually vomiting.
• Be aware of vomiting without diarrhoea.
• Rapid breathing with no cough or fever
• Abdominal pain – can be severe.

Call for assistance if you have symptoms that worry you or that are not responding to your efforts to treat them. If you have abdominal pain or difficulty breathing, go straight to the hospital.

• Have a sick day plan in place as discussed with your healthcare team.

 Take medication as suggested by your pharmacist, nurse, or doctor to relieve the symptoms of your cold or flu.  Be aware that some preparations may contain some sugar – discuss this with the pharmacist. If you are not getting better or start to feel worse call your doctor.

 What you should have on hand

• Blood glucose meter.
• Glucose test strips.
• Other medication.
• Quick-acting carbs, such as fruit juice, sugary drinks or sweets.
• Water.
• Insulin and ketone test strips.
• Glucagon.
• Contact details of your healthcare team in case of emergency.

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Dr Paula Diab stresses that every complication of foot disease relating to diabetes is preventable and gives guidelines to spot these complications in early stages.

Foot disease is probably one of the most feared aspects of diabetes. Almost everyone has a horror story about a friend or neighbour or sometimes tragically, a relative, who developed foot disease, gangrene or needed an amputation.

The statistics relating to foot disease are horrifying but what is worse, is that almost every single complication related to foot disease is entirely preventable. It’s not normal for people with diabetes to get foot ulcers and then need an amputation; it’s only through poor diabetes management that you lose sensation and circulation in the feet.

Educating yourself and knowing the signs and symptoms to look out for can radically improve your chances at retaining healthy feet despite having diabetes.

What causes diabetic foot disease?

You may have heard about macro- and microvascular complications related to diabetes. This refers to whether the large (macro) or small (micro) vessels in the body are affected. Foot disease can be caused by both macrovascular or microvascular disease which it is probably why is such a common complication.

Macrovascular disease occurs when blood circulation from the heart is diminished either through excessive glucose or cholesterol deposits in the vessels or narrowing due to high blood pressure. This reduces the blood flow into the distal peripheries and the feet are usually the first to show signs of this lack of circulation. Smoking and other cardiovascular risk factors will also enhance this risk and further slowdown blood flow.

Microvascular disease caused by persistently high glucose levels affects the nerves in the feet. When these become damaged, you may feel pain, tingling or even numbness in the feet.

These two mechanisms can also occur simultaneously when a loss of sensation in the feet can make it difficult to discern when you have a blister, minor cut or injury on the foot. As these minor injuries are left untreated, infection can set in causing bigger wounds or even ulceration. Due to blood flow being restricted, healing is further delayed, and the wound progresses even more.

Sometimes infections become so deeply invasive that intravenous antibiotics, surgical debridement or hospitalisation are required. High blood glucose levels can cause the arteries to become stiff and prevent blood flow to the feet.

What are the signs and symptoms of foot disease?

The most common symptoms of damage to the feet is increased swelling of the legs and feet or a change in skin colour on the feet. This usually manifests as a purple discolouration of the skin around the ankles or mottling of the skin. You may also notice a decrease in the hair growth on the top of your feet or lower leg.

All these symptoms are due to the decreased blood flow and poor circulation of blood from the heart. Nerve damage initially causes burning or tingling in the feet and then develops into a lack of sensation and numbness. This may happen intermittently at first but then begins to become more obvious and more difficult to treat.

Delayed healing of wounds, cracks and blisters on the feet are more advanced signs of foot damage.

Please also pay careful attention to ingrown toenails, warts, corns, calluses, bunions and hammertoes. These minor deformities often result in abnormal gait (the manner in which you walk) and as a result puts pressure on areas of the feet where you would not normally. This results in damage to the nerves and further enhances the risk of microvascular damage.

There are also nerves in the body over which you have no control. These are called autonomic nerves and control functions such as digestion, sweating and temperature regulation in the body. They too can be damaged by diabetes and may cause dryness, cracks, fissures, blisters and callus formation in the feet, all of which may lead to secondary infections and damage.

How should you take care of your feet?

As with all complications of diabetes, the basic control of glucose levels is of huge importance. Check your levels regularly and seek expert advice when they are not in target. Regular exercise can also prevent foot disease and promote good blood flow in the feet.

All that we require with regard to exercise is that you are simply more active today than you were yesterday. Aim to do 20-30 minutes of moderate intensity cardiovascular activity a day on most days of the week. Walking, jogging, swimming, cycling or even sustained household chores, such as mowing the lawn or vacuuming, may count towards this activity.

Other important footcare advice

• Wash your feet every day with lukewarm (not hot) water and mild soap.
• Dry your feet well, especially between the toes. Use a soft towel and pat gently but don’t rub the feet too vigorously.
• Keep the skin of your feet smooth by applying a cream or lanolin lotion, especially on the heels. If the skin is cracked, talk to your doctor about how to treat it.
• Keep your feet dry by dusting them with non-medicated powder before putting on shoes, socks or stockings.
• Check your feet every day. You may need a mirror to look at the underside of your feet. Call your doctor if you have redness, swelling or pain that doesn’t go away, numbness or tingling in any part of your foot.
• Don’t treat calluses, corns or bunions without talking to your doctor first.
• Cut toenails straight across to avoid ingrown toenails. It might help to soak your toenails in warm water to soften them before you cut them. File the edges of your toenails carefully.
• Don’t let your feet get too hot or too cold.
• Don’t walk barefoot. This is to prevent injuries to your feet.
• Avoid putting your feet in front of a fire in winter to warm then, if they have lost sensation you could end up with burns or blisters which you do not feel.
• Avoid using hot water bottles to warm your feet in winter as the bottle may be too hot and also cause blisters if your nerves are damaged.

Choosing footwear

You certainly don’t need high fashion or expensive footwear in diabetes. But you also don’t have to wear big bulky boots that look ugly. Here are important tips to consider when choosing your footwear:

• Try not to wear shoes without socks as they protect the feet and prevent excessive sweating and pressure from the shoes.
• Ensure that your socks are good quality and not worn or frayed that will cause damage to the feet.
• Avoid open sandals or shoes where feet are not adequately protected from external injury.
• Avoid high-heeled shoes and shoes with pointed toes that will change the architecture of the feet.
• Wear well-padded socks or stockings in winter. Don’t wear stretch socks, nylon socks, socks with an elastic band or garter at the top, or socks with inside seams as these place undue stress on the skin and constrict blood flow.
• Don’t wear uncomfortable or tight shoes that rub or cut into your feet. If you’ve had problems before because of shoes that didn’t fit, you may want to be fitted for a custom-moulded shoe.
• Talk to your doctor or podiatrist before you buy special shoes or inserts.
• Shop for new shoes at the end of the day when your feet are a little swollen. If shoes are comfortable when your feet are swollen, they’ll probably be comfortable all day.
• Break in new shoes slowly by wearing them for no more than an hour a day for several days.
• Change socks and shoes every day. Have at least two pairs of regular shoes so you can switch pairs every other day.
• Look inside your shoes every day for things like gravel or torn linings. These things could rub against your feet and cause blisters or sores.

Seek help

If you do develop some type of wound on your feet, please get it seen to as soon as possible. Don’t wait until it’s too late before you seek help.

Your doctor, diabetic nurse educator or podiatrist can all examine the feet on a regular basis to test a variety of different functions and help prevent further injury and infection.

It’s also good practice to examine your own feet on a regular basis. Look for changes in skin colouration, hair growth and new sores or blisters that may have developed. Look at your feet at the end of the day when you remove your shoes and make sure that the shoes are not damaging your feet in any way. You should also make sure that a healthcare practitioner examines your feet at least once a year. If there are any concerns or changes, you should see a podiatrist immediately and treat the problem in its early stages.

The old adage prevention is better than cure is certainly true of foot disease. Regular exercise, monitoring your blood glucose levels and keeping them well-controlled and stopping smoking will go a long way to ensuring that you don’t land up under the surgeon’s knife or with complex infections.

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Insulin has been available for a century and has gone from poorly defined animal insulin to pure and precisely controlled formulations. Dr Louise Johnson tells us more about this miracle treatment.

History of insulin

The discovery of insulin, the miracle treatment, is attributed to a group at the university of Toronto, Canada. In 1922, a 22-year-old physician, Frederick G Banting, worked in a laboratory to test his idea that pancreas extracts will reduce blood glucose levels in diabetic dogs. Banting was assisted by a student, Charles Best. This led to the first successful test of insulin in a 14-year-old boy, Leonard Thompson.

In January 1922, this boy with diabetes received the first dose of purified animal insulin and his life was saved. Leonard Thompson lived another 13 years to be 27 years and he passed away due to bronchopneumonia.

What is insulin?

Insulin is a hormone produced by the beta cells of the pancreas called the islet cells of Langerhans, in a response to reduce blood glucose. It works on cellular level to allow sugar to enter each cell by opening a channel in the cell. Glucose enters the cells and is used inside the cell to produce energy. The organs that are highly insulin dependent are the muscle, liver and fat.

Who needs insulin?

All living creatures needs insulin for uptake of glucose to be used as a source of energy.

Insulin is the primary treatment for people living with Type 1 diabetes since they have no endogenous or own insulin. They were previously called insulin-dependent diabetes mellitus (IDDM).

People with Type 2 diabetes, previously called non-insulin-dependent diabetes mellitus (NIDDM), also requires insulin at some time during their disease. As time progresses, the amount of the beta cells of the pancreas diminish and a supplementation with once-daily insulin, called basal insulin, is needed.

In Type 2 diabetes with insulin resistance where more insulin is needed, supplementation would also be required. The treatment of Type 2 diabetes always included diet, exercise, metformin, other antidiabetic agents such as incretins, SGLT2 inhibitors and sulphonylureas. When the HbA1c is above 7.5% on these regimens’ insulin supplementation is needed.

How do miracle treatment injections work?

Insulin is injected in the subcutaneous fat layer (just beneath the skin) on the abdomen, upper thigh, arm and buttocks. Once injected in the subcutaneous layer, it’s not immediately absorbed in the bloodstream. The insulin molecule first dissociates into dimers and monomers before being absorbed.

Insulin initiation

Patients with Type 1 diabetes require insulin immediately and usually multiple daily dosages to cover both mealtime and sleeping glucose levels. This regime is called basal-bolus insulins.

The preferred method on insulin initiation in Type 2 diabetes will be to add a once-daily long-acting insulin when needed. If glucose targets are not met, then a mealtime insulin or bolus insulin will be added according to the need.

Types of insulin

1. Basal insulin therapy
2. Bolus insulin therapy
3. Premixed insulin
4. Concentrated insulin
5. Inhaled insulin

1. Basal insulin therapy

Manipulating various side chains of the insulin molecule has permitted availability of long-acting insulin, such as glargine, determir and degludec (Lantus, Basaglar, Optisulin, Toujeo, Tresiba).

These long-acting insulins are peak less with a long duration of action. Basal insulin slows the production of glucose from the liver. In a fasting state this will maintain glucose homeostasis.

In general, basal insulin is administered once-daily in 24-hour cycle at the same time every day. It’s important that basal insulin should always be administered regardless of food intake as this serves as the background insulin normally secreted by the pancreas.

NPH insulin (Protophane) is one of the oldest basal insulin and because of its shorter lifespan needed to be injected twice a day. It has been available since 1964. The primary advantage of NPH is financial as it is typically less costly than the newer long-acting insulins. The downside of NPH is that it does make a small peak which can lead to hypoglycaemic events.

2. Bolus insulin therapy

Bolus insulin is rapid-acting insulin that can be given before meals to reduce mealtime peaks of sugar. The combination of basal and bolus insulin is a flexible regime.

The newer short-acting insulins are called analogues (Novorapid, Apidra, Humalog, FiAspart). Analogues differ from human preparation (regular insulin) by small substitutions in amino acid chains which in turn prevent formation of polymers or hexamers.

The onset and peak action of rapid-acting insulin analogues more closely resemble endogenous (own) human insulin secreted in response to a meal.

Due to the fact that it is rapid-acting insulin, it can be given before, during or directly after a meal. The mealtime dosage of insulin can be calculated according to the amount of carbohydrates in the meal. Patients with a varying appetite can increase, decrease or omit the mealtime insulin according to the carbohydrates in the meal.

3. Premix insulin

Premix insulin preparations is a combination of short-acting and intermediate/long-acting insulin in a fixed ratio. Although this provides convenience for some and may be appealing to those who refuse to inject more than twice a day, it does not allow for flexibility in mealtime or changes in the ratio of short to long-acting insulin doses.

An example is Novomix which is a fix combination of 70% NPH (protophane) and 30 % Novorapid. Another example is Ryzodeg which is a combination of 70 % degludec (Tresiba) and 30% insulin aspart (Novorapid). The numbers expressed in the ratio after the insulin refer to the percentage of insulin in the premix solution. An example is Humalog 25 which has 75 % long-acting and 25% short-acting insulin.

4. Concentrated insulin

Insulin that is two to three times more concentrated than the normal U 100 insulin is now available. The available concentrated insulin in South Africa is glargine U300 (Toujeo).

The positive effect of more concentrated insulin is that the volume that is needed to inject is smaller in patients that are severe insulin resistant and need high volume insulin.

Humalog U500 is a short-acting concentrated insulin that is available on special request in severe insulin resistant patients that need more that 200 units per day.

5. Inhaled insulin

The least often used preparation is human insulin inhalation powder (Alfrezza), however this is not available in South Africa. It’s administered at the beginning of a meal. Lung function must be assessed before initiation and after six months and thereafter yearly. It’s contraindicated in patients with lung disease and asthma.

Insulin sliding scale

Although commonly utilised in hospitals when patients are acutely ill, it’s not recommended as a routine method of insulin management. The reason for this is that it causes extreme fluctuations of glucose values which are far worse than continuous slightly elevated blood glucose. The best method to use short-acting insulin is via carbohydrate counting before meals.

Side effects of the miracle treatment

Hypoglycaemia

The most severe side effect is hypoglycaemia. It’s important that all diabetic patients on medication know how to treat the symptoms of low blood sugar. Usually if glucose is below 4.0 mmol, 15 gram of carbs is indicated. This can be in the form of a small fruit juice.

It’s important that all diabetic patients on insulin have a glucagon hypo kit at home for their spouse or parent to administer should the patient not respond. Always recheck the glucose after an episode of hypoglycaemia and try to establish the cause. If hypoglycaemia occurs frequently speak to your doctor for a thorough evaluation.

Weight gain

It was clearly shown in the UKPDS study that patients on insulin gain 5 to 8kg over a 10-year period. To prevent weight gain, try to limit carbohydrates and prevent hypoglycaemia. Should you pick up weight speak to your doctor. Remember that underactive thyroid disease can be associated with diabetes.

Lipodystrophy

Lipodystrophy is hardened fat tissue. This happens when you are injecting on the same place every time and it causes poor insulin absorption. To prevent this from happening, it’s important to rotate the injection sited daily

Insulin has now been available for 100 years and this miracle treatment for diabetes has saved many lives and prevents many complications if used correctly. Remember that insulin is not the enemy but in persons with diabetes, it’s your best friend.

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