Diabetes can be a frustrating and challenging disease to treat. An additional new class of drug, a once-daily injection, is now available for type 2 diabetes patients.
A NEW once-daily diabetes jab to help maintain control over blood glucose levels and reduce weight was recently launched in Malaysia by Novo Nordisk.
Liraglutide, a once-daily human glucagon-like peptide-1 (GLP-1) injection, is said to help patients achieve normal blood sugar levels. The injection can be taken at any time of the day, irrespective of meals.
“Liraglutide represents an important advancement in the treatment of type 2 diabetes. It is a new drug to control diabetes, and it reduces blood sugar only when the sugar level is high. Thus, it avoids a common side effect of other medications, namely, low blood sugar (hypoglycaemia),” says Sanjeev Shishoo, vice president of Novo Nordisk, Oceania and South East Asia.
Malaysia is the first Asean country to launch the drug, he says. Liraglutide is available in 30 countries, including the United States, Canada, Britain, Germany, France, Denmark, Japan, Russia and India, since it was first launched a year ago.
In an extensive clinical development programme prior to the launch, 4,445 patients (18 to 80 years old) with type 2 diabetes in 41 countries (including Malaysia) received the injections.
Different class
Diabetes is a metabolic condition where people experience raised blood sugar levels because of either a partial or complete reduction of insulin production in their body.
GLP-1, a key hormone, appears impaired in people with type 2 diabetes and may be a reason why they are at risk for abnormally high blood glucose levels.
Incretins are hormones in the human gut that help the body process sugar properly. Incretin-based therapies represent a new class of treatment for type 2 diabetes.
Natural GLP-1 also has other benefits, such as reducing appetite, lowering blood pressure, and improving heart function.
Many complications
Diabetes results in enormous health costs due to the many serious complications that arise from the condition (blindness, kidney failure, limb amputations, and cardiovascular disease, to name a few).
Less than 5% are type 1 diabetes, while the most common is type 2 diabetes, which makes up 95% of cases.
The causes of type 2 diabetes are insufficient insulin produced by the pancreas, insulin resistance, and overproduction of glucose by the liver, all of which give rise or cause hyperglycaemia (high blood glucose), says Prof Datuk Dr Mafauzy Mohamed, senior consultant endocrinologist at Hospital Universiti Sains Malaysia.
“Overproduction of glucose is due to the lack of insulin to suppress the liver from producing glucose. Secondly, glucagon (level) is rather high,” says Prof Mafauzy, who is also director of the Health Campus, Universiti Sains Malaysia.
Glucagon (hormone) allows the liver to produce glucose, especially during fasting. In type 2 diabetes, the liver still produces glucose even though the glucagon level is high, he notes.
Diabetics, he says, have two to four times the risk of dying from heart attack or stroke. Life expectancy of people with diabetes is reduced by five years due to complications.
Diabetes is the number one cause of renal failure, adult onset blindness and non-traumatic amputations. Some 60% to 70% of patients have nerve damage if diabetes is not controlled (for example, injuries to feet and impotence in males).
A global problem
Presently, 285 million people in the world have diabetes, and the number is expected to rise to 438 million by 2030, reveals Prof Mafauzy.
The rate of increase in diabetes cases is staggering. In Malaysia alone, 1.8 million people were diagnosed with diabetes in 2010, a significant increase from 1.4 million in 2006.
“In 1986, the national prevalence of diabetes was 6.3%; in 2006, it was 15% (14.9%). That’s almost a 150% increase in the rate of diabetes over 20 years,” Prof Mafauzy says.
By 2030, it is predicted that an estimated 2.5 million people will be diagnosed with diabetes in Malaysia.
Prof Mafauzy says Indians (19.9%) top the ethnic groups of people with diabetes, followed by Malays (11.9%), and Chinese (11.4%).
In 2010, diabetes was responsible for more than 23,800 deaths in Malaysia. Premature deaths due to diabetes can be prevented or delayed by 10 to 20 years if diabetes is kept under control, Prof Mafauzy emphasises.
Previously, diabetes was thought to be “a disease of the rich.” That’s not so now. “There is only a 2% difference of people with diabetes in the rural areas (10.5%) compared to urban areas (12.1%). Even in the West, rural folks have a higher incidence of diabetes than urban folks, he says.
Diabesity
The increase in cases of diabetes is due to increasing affluence and obesity. “There is a joke that Malaysians are on a “see-food” diet. We eat whatever we see. We’re constantly eating (except when sleeping),” Prof Mafauzy says.
“The main cause of diabetes now is obesity or diabesity (obesity related diabetes),” he notes.
Two-thirds of diabetics are overweight or obese. If they had better control over their weight, the prevalence of diabetes could be reduced by half.
If your body mass index (BMI) is more than 40, you’re close to six or seven times the risk of getting diabetes than if you are of normal weight (BMI of 18 to 25).
The prevalence of overweight and obesity has doubled in 10 years. In 1996, the prevalence of overweight and obesity was 21%, but in 2006, the prevalence went up to 43% (almost double), notes Prof Mafauzy.
Treating diabetes
Oral monotherapy, oral combination, oral-insulin combinations, and multiple insulin injections are some of the ways of treating diabetes.
In Malaysia, the control of diabetes is deemed “not satisfactory” and is causing a high prevalence of related complications. Consultant endocrinologist Prof Datuk Dr Khalid Abdul Kadir says despite medications (oral tablets or insulin injections) to treat diabetes, more than 70% of patients do not achieve the level of blood sugar accepted as control targets.
As type 2 diabetes progresses, sugar control deteriorates. Patients are started on oral medicines. Then two or more medications are combined to control blood sugar. With multiple medications, there is an increased risk of hypoglycaemia and weight gain, says Prof Khalid.
“There is a need for better control of blood sugar; perhaps one agent that will not cause increase in weight, but a decrease, because diabetes is also called “diabesity”, which is diabetes and obesity. If we can reduce obesity, we can reduce problems associated with diabetes,” he emphasises.
He speaks about a new understanding on the mechanism of glucose control due to the identification of “new” gut hormone, GLP-1. “In normal individuals, gut hormones play an important role in blood glucose control. When the small gut detects food, it starts secreting gut hormones which circulate in the blood and have specific effects on the body in response to what you eat,” he says.
“If you don’t eat and drink water only, you don’t produce this hormone. If you drink Coca-Cola, the levels go up very high,” he says. The development of liraglutide is based on this GLP-1 hormone.
Prof Khalid says: “Liraglutide is able to bring type 2 diabetes to sustained target glucose level and there is low risk of hypoglycaemia. Within 26 weeks, patients can lose on an average up to 3.4kg of weight with liraglutide.” In patients who are overweight, the weight loss is even more pronounced.
Liraglutide is available as a simple pen device, along with one of the thinnest needles around, that makes injection virtually painless. One injection can last up to 24 hours, hence the drug is administered only once daily.
The pre-filled, multi-dose pen delivers doses of 0.6mg, 1.2mg or 1.8mg of the drug. The cost of the injection for a month is about RM650 (on 1.2mg dose daily).
Liraglutide is recommended for patients with type 2 diabetes who are unable to achieve normal blood sugar level with one or two anti-diabetic drugs.
It should not be used in patients with type 1 diabetes mellitus, or for the treatment of diabetic ketoacidosis. Liraglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
This is because animal data has shown that that a rare type of thyroid cancer, known as medullary thyroid cancer, is associated with liraglutide, although the relevance of this finding to humans remains unknown.
The US Food and Drug Adminstration has “approved liraglutide because the Agency believes that the benefits of this drug to patients with type 2 diabete mellitus outweigh potential risks associated with its use. To ensure that the benefits continue to outweigh any risks, the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) as part of the drug approval. This REMS includes a patient Medication Guide and a Communication Plan.
“FDA has also required additional studies to better understand the risks associated with this medicine, in addition to a large cardiovascular safety trial, that is now required as part of the development of most diabetic medications.”
A NEW once-daily diabetes jab to help maintain control over blood glucose levels and reduce weight was recently launched in Malaysia by Novo Nordisk.
Liraglutide, a once-daily human glucagon-like peptide-1 (GLP-1) injection, is said to help patients achieve normal blood sugar levels. The injection can be taken at any time of the day, irrespective of meals.
“Liraglutide represents an important advancement in the treatment of type 2 diabetes. It is a new drug to control diabetes, and it reduces blood sugar only when the sugar level is high. Thus, it avoids a common side effect of other medications, namely, low blood sugar (hypoglycaemia),” says Sanjeev Shishoo, vice president of Novo Nordisk, Oceania and South East Asia.
Malaysia is the first Asean country to launch the drug, he says. Liraglutide is available in 30 countries, including the United States, Canada, Britain, Germany, France, Denmark, Japan, Russia and India, since it was first launched a year ago.
In an extensive clinical development programme prior to the launch, 4,445 patients (18 to 80 years old) with type 2 diabetes in 41 countries (including Malaysia) received the injections.
Different class
Diabetes is a metabolic condition where people experience raised blood sugar levels because of either a partial or complete reduction of insulin production in their body.
GLP-1, a key hormone, appears impaired in people with type 2 diabetes and may be a reason why they are at risk for abnormally high blood glucose levels.
Incretins are hormones in the human gut that help the body process sugar properly. Incretin-based therapies represent a new class of treatment for type 2 diabetes.
Natural GLP-1 also has other benefits, such as reducing appetite, lowering blood pressure, and improving heart function.
Many complications
Diabetes results in enormous health costs due to the many serious complications that arise from the condition (blindness, kidney failure, limb amputations, and cardiovascular disease, to name a few).
Less than 5% are type 1 diabetes, while the most common is type 2 diabetes, which makes up 95% of cases.
The causes of type 2 diabetes are insufficient insulin produced by the pancreas, insulin resistance, and overproduction of glucose by the liver, all of which give rise or cause hyperglycaemia (high blood glucose), says Prof Datuk Dr Mafauzy Mohamed, senior consultant endocrinologist at Hospital Universiti Sains Malaysia.
“Overproduction of glucose is due to the lack of insulin to suppress the liver from producing glucose. Secondly, glucagon (level) is rather high,” says Prof Mafauzy, who is also director of the Health Campus, Universiti Sains Malaysia.
Glucagon (hormone) allows the liver to produce glucose, especially during fasting. In type 2 diabetes, the liver still produces glucose even though the glucagon level is high, he notes.
Diabetics, he says, have two to four times the risk of dying from heart attack or stroke. Life expectancy of people with diabetes is reduced by five years due to complications.
Diabetes is the number one cause of renal failure, adult onset blindness and non-traumatic amputations. Some 60% to 70% of patients have nerve damage if diabetes is not controlled (for example, injuries to feet and impotence in males).
A global problem
Presently, 285 million people in the world have diabetes, and the number is expected to rise to 438 million by 2030, reveals Prof Mafauzy.
The rate of increase in diabetes cases is staggering. In Malaysia alone, 1.8 million people were diagnosed with diabetes in 2010, a significant increase from 1.4 million in 2006.
“In 1986, the national prevalence of diabetes was 6.3%; in 2006, it was 15% (14.9%). That’s almost a 150% increase in the rate of diabetes over 20 years,” Prof Mafauzy says.
By 2030, it is predicted that an estimated 2.5 million people will be diagnosed with diabetes in Malaysia.
Prof Mafauzy says Indians (19.9%) top the ethnic groups of people with diabetes, followed by Malays (11.9%), and Chinese (11.4%).
In 2010, diabetes was responsible for more than 23,800 deaths in Malaysia. Premature deaths due to diabetes can be prevented or delayed by 10 to 20 years if diabetes is kept under control, Prof Mafauzy emphasises.
Previously, diabetes was thought to be “a disease of the rich.” That’s not so now. “There is only a 2% difference of people with diabetes in the rural areas (10.5%) compared to urban areas (12.1%). Even in the West, rural folks have a higher incidence of diabetes than urban folks, he says.
Diabesity
The increase in cases of diabetes is due to increasing affluence and obesity. “There is a joke that Malaysians are on a “see-food” diet. We eat whatever we see. We’re constantly eating (except when sleeping),” Prof Mafauzy says.
“The main cause of diabetes now is obesity or diabesity (obesity related diabetes),” he notes.
Two-thirds of diabetics are overweight or obese. If they had better control over their weight, the prevalence of diabetes could be reduced by half.
If your body mass index (BMI) is more than 40, you’re close to six or seven times the risk of getting diabetes than if you are of normal weight (BMI of 18 to 25).
The prevalence of overweight and obesity has doubled in 10 years. In 1996, the prevalence of overweight and obesity was 21%, but in 2006, the prevalence went up to 43% (almost double), notes Prof Mafauzy.
Treating diabetes
Oral monotherapy, oral combination, oral-insulin combinations, and multiple insulin injections are some of the ways of treating diabetes.
In Malaysia, the control of diabetes is deemed “not satisfactory” and is causing a high prevalence of related complications. Consultant endocrinologist Prof Datuk Dr Khalid Abdul Kadir says despite medications (oral tablets or insulin injections) to treat diabetes, more than 70% of patients do not achieve the level of blood sugar accepted as control targets.
As type 2 diabetes progresses, sugar control deteriorates. Patients are started on oral medicines. Then two or more medications are combined to control blood sugar. With multiple medications, there is an increased risk of hypoglycaemia and weight gain, says Prof Khalid.
“There is a need for better control of blood sugar; perhaps one agent that will not cause increase in weight, but a decrease, because diabetes is also called “diabesity”, which is diabetes and obesity. If we can reduce obesity, we can reduce problems associated with diabetes,” he emphasises.
He speaks about a new understanding on the mechanism of glucose control due to the identification of “new” gut hormone, GLP-1. “In normal individuals, gut hormones play an important role in blood glucose control. When the small gut detects food, it starts secreting gut hormones which circulate in the blood and have specific effects on the body in response to what you eat,” he says.
“If you don’t eat and drink water only, you don’t produce this hormone. If you drink Coca-Cola, the levels go up very high,” he says. The development of liraglutide is based on this GLP-1 hormone.
Prof Khalid says: “Liraglutide is able to bring type 2 diabetes to sustained target glucose level and there is low risk of hypoglycaemia. Within 26 weeks, patients can lose on an average up to 3.4kg of weight with liraglutide.” In patients who are overweight, the weight loss is even more pronounced.
Liraglutide is available as a simple pen device, along with one of the thinnest needles around, that makes injection virtually painless. One injection can last up to 24 hours, hence the drug is administered only once daily.
The pre-filled, multi-dose pen delivers doses of 0.6mg, 1.2mg or 1.8mg of the drug. The cost of the injection for a month is about RM650 (on 1.2mg dose daily).
Liraglutide is recommended for patients with type 2 diabetes who are unable to achieve normal blood sugar level with one or two anti-diabetic drugs.
It should not be used in patients with type 1 diabetes mellitus, or for the treatment of diabetic ketoacidosis. Liraglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
This is because animal data has shown that that a rare type of thyroid cancer, known as medullary thyroid cancer, is associated with liraglutide, although the relevance of this finding to humans remains unknown.
The US Food and Drug Adminstration has “approved liraglutide because the Agency believes that the benefits of this drug to patients with type 2 diabete mellitus outweigh potential risks associated with its use. To ensure that the benefits continue to outweigh any risks, the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) as part of the drug approval. This REMS includes a patient Medication Guide and a Communication Plan.
“FDA has also required additional studies to better understand the risks associated with this medicine, in addition to a large cardiovascular safety trial, that is now required as part of the development of most diabetic medications.”
