Glyxambi (Linagliptin + Empagliflozin)

How is Glyxambi type 2 diabetes treated with medication? Non-medication therapy, also known as baseline therapy, is the basis of treatment for type 2 diabetes. Baseline therapy includes education, dietary changes, increased physical activity, and, if necessary, weight loss and tobacco cessation. Drug therapy should be initiated only when these measures are insufficient to achieve individual therapy goals, according to the National Health Care Directive “Type 2 Diabetes”.

Diabetes mellitus is a severe disease of metabolic genesis, characterized by the development of symptoms due to hyperglycemia – an increase in blood glucose levels. Such changes lead to numerous complications in almost all internal organs.

The kidneys, the cardiovascular, central, and peripheral nervous system, and the organs of vision are affected, hormonal disorders are often reported, and the trophic and tissue regeneration rate is impaired. The only way to stop such symptoms is long-term drug therapy. Diabetes pills or insulin injections are the only way to treat a patient with such pathology.

Briefly, insulin secretion occurs in the cells of the islets of Langerhans pancreas. It is not released into the bloodstream immediately, but accumulates inside the cells and is released when glucose enters.

This hormone regulates its metabolism, providing for its breakdown in the liver, transformation in muscle tissue, and deposition as glycogen. Naturally, the disruption of these metabolic processes entails changes in the work of the entire body. According to endocrinologists, diabetes mellitus is dangerous precisely because of its complications, which sometimes become the cause of death, especially in elderly patients.

Despite the similarity of the clinical picture, there are several forms of the disease, which differ according to the pathogenetic mechanisms of occurrence:

1. Type 1 diabetes (until recently it was called insulin-dependent). The pathology is based on the destruction of insulin-producing cells as a result of autoimmune reactions, viral infection, and complex genetic disorders. As a rule, it appears at an early age and sometimes occurs in children.
2. Type 2 diabetes (previously it was called insulin-independent). In this form of the disease, insulin production remains the same, but the tissues are insensitive to its action. But with a long course, the level of production of this hormone also decreases under the influence of constantly high concentrations of glucose in the bloodstream. Usually, it is diagnosed in patients of advanced age.

A separate group of pathologies includes gestational diabetes, which develops against the background of changes that occur during fetal gestation. Often this disease can cause serious disorders in the newborn child. In isolated cases, there are more rare forms of diabetes, resulting from congenital and acquired abnormalities.

Accordingly, the principles of treatment of diabetes differ. With insufficient insulin production, antidiabetic drugs will be ineffective. It is necessary to inject the hormone in a dosage that mimics the physiological work of the cells of the pancreas. In type 2 disease, the only therapy option is diabetes pills that reduce glucose levels. And only when there is a combination of tissue resistance to insulin with its insufficient production, injections are necessary.

The main indication for the prescription of drugs that reduce blood sugar levels is a positive blood test result. Normally, this figure should be between 3.3 and 5.5 mmol/l. If the obtained value exceeds the upper limit, additional examinations are indicated. Glucose tolerance tests to determine fasting sugar and glucose load, glycated hemoglobin concentration, pancreatic ultrasound, and other diagnostic procedures are appointed.

Glyxambi Uses

What is Glyxambi: available studies have shown that Glyxambi may reduce the incidence of diabetes-related cardiovascular events and overall mortality (insufficient evidence studies). Initially, gastrointestinal complaints such as nausea, loss of appetite, abdominal pain, vomiting, and diarrhea may often occur when taking Glyxambi.

In addition, taste sensations may change, for example. Therefore, treatment starts with low Glyxambi dosing and slowly increases. The use of Glyxambi is limited, especially in renal insufficiency. Kidney function should be checked every 3-6 months while taking Glyxambi. If the estimated glomerular filtration rate (eGFR) is below 30 mL/min, Glyxambi should be discontinued as recommended by the German Diabetes Society.

According to WHO, diabetes mellitus is a real problem in the modern world, and people of different ages and sexes are at risk. Today diabetes mellitus already affects more than half a billion people in the world, the disease is in third place in the ranking of diseases and mortality, not reaching the stage of cardiovascular system pathologies, which is still in first place in the rating of diseases.

What is diabetes mellitus, and what is the widespread, catastrophic number of patients? It is an endocrine pathology, which is expressed in disorders of production of the pancreatic hormone insulin. Simply put, glucose is produced in large quantities and has no time to be utilized, which is why its concentration increases dramatically, which subsequently leads to the development of symptoms of diabetes.

Since there are two types of diabetes – the first and second, the first type is a congenital disease in which the pancreas does not produce insulin in any way, so diabetic patients are called insulin-dependent. The second type is acquired during life. Knowing what kind of lifestyle the people live, doctors may predict whether they are at risk of developing diabetes or not. An unbalanced diet, obesity, lack of exercise, bad habits, and heredity lead to dire consequences. Moreover, diabetes can be complicated by other diseases: hypertension, stroke, myocardial infarction, atherosclerosis of the brain and heart vessels, angina, coronary heart disease, etc.

What in such cases should be done so as not to get diabetes and not to suffer from its consequences? First of all, a doctor or endocrinologist (this disease is treated by the endocrinologist) should assign all the necessary laboratory examinations (tests for glucose in the blood and urine, thyroid hormone tests, ultrasound examination of the thyroid gland, abdomen, and so on). Then, based on the results, the doctor makes a specific conclusion, gives you a diagnosis, and prescribes proper treatment.

Indications of Use

The indications for Glyxambi are always a list of symptoms for the treatment for which the drug is prescribed. A complete list of indications for the drug Glyxambi can be found in an Israeli pharmacy.

The instructions allow Glyxambi to be prescribed exclusively to people with type 2 diabetes. As a rule, it is a 2nd line drug; it is introduced into the treatment regimen when dietary correction, exercise, and Glyxambi in optimal or marginal dosage ceases to provide sufficient compensation for diabetes mellitus.

Glyxambi medication is indicated for treating adult patients with type 2 diabetes as an adjunct to diet therapy and an active lifestyle for the best glycemic index result.
It is used as monotherapy, especially if the patient cannot tolerate other hypoglycemic drugs like Glyxambi, or if the patient has severe renal diseases. Glyxambi is also prescribed for the combined treatment of patients with diabetes in combination with other hypoglycemic drugs, including insulin.

How the Drug Works

The hormone incretins are directly involved in reducing glucose to physiological levels. Their concentration increases in response to glucose entering the blood vessels. The result of the work of the incretins is an increase in insulin synthesis and a decrease in glucagon, which causes a drop in glycemia.

Incretins are rapidly degraded by special DPP-4 enzymes. Glyxambi drug can bind with these enzymes, slow down their work, and thus prolong the life of insulin and increase the release of insulin into the blood in diabetes

The undoubted advantage of Glyxambi is the excretion of the active ingredient mainly with the bile through the intestines. According to the instructions, not more than 5% of linagliptin empagliflozin combination  gets into the urine, and even less is metabolized in the liver. What is Glyxambi price? Glyxambi cost around $610 for a supply of 30 tablets.

Instructions for Use

Instructions for using the drug Glyxambi (linagliptin) are inside the package. We recommend that you use the medication strictly according to the instructions or recommendations of the doctor. Do not change the dose. 

Contents of Glyxambi

The composition of the preparation of Glyxambi consists of a mixture of active ingredients and minor ingredients. If you need to see the composition of the preparation Glyxambi (Glyxambi, linagliptin), you can find it on the leaflet with the instructions for the drug.

Glyxambi Alternatives

Glynides

These include substances such as Repaglinide and Nateglinide. Like sulfonylurea, glinides also increase insulin production and release in the pancreas, regardless of current blood glucose levels. In contrast to sulfonylureas, their effects are rapid and short-lived. The risk of hypoglycemia still exists, but it is much lower. Glynides are taken before meals and can slow the rise in blood sugar caused by food intake. This is especially suitable for people who eat irregularly.

The short duration of action makes flexible use possible compared to sulfonylurea. In addition, glinides, like sulfonylurea, can lead to weight gain and gastrointestinal complaints such as abdominal pain, nausea, and diarrhea. Because of the lack of evidence of their therapeutic benefit, glinides are currently used to treat type 2 diabetes only in justified exceptional situations.

DPP-4 Inhibitors

These include substances such as Saxagliptin, Sitagliptin, Vildagliptin, and Empagliflozin+Linagliptin. The use of DPP-4 (dipeptidyl peptidase-4) inhibitors suppresses the DPP-4 enzyme in the blood. This slows down the breakdown of certain gut hormones in the blood that stimulate insulin release. As a result, blood sugar levels drop after a meal, but not on an empty stomach. They also reduce sugar production in the liver. With monotherapy, the risk of hypoglycemia is small.

In addition, there is no known evidence of weight gain or reduced effect with long-term use. Available studies by 2022 have not yet been able to prove whether they can prevent comorbidities and secondary diseases associated with diabetes.

DPP-4 inhibitors can be combined with other antidiabetic drugs, and fixed dose combination of empagliflozin and linagliptin tablets (e.g., Glyxambi and sitagliptin in a single tablet) are also available. Examples of typical glyxambi side effects include upper respiratory and urinary tract infections, gastrointestinal complaints and symptoms of fatigue, skin rash, headache and dizziness, sinusitis, gastrointestinal disturbances, and/or pancreatitis.

SGLT2 Inhibitors

These include substances such as Dapagliflozin, Empagliflozin, Ertugliflozin, and Canagliflozin. SGLT2 (sodium-glucose co-transporter 2) inhibitors lower blood sugar levels by blocking the SGLT2 enzyme in the kidneys. Without the enzyme, less sugar (glucose) enters the blood from the kidneys, and more glucose is excreted through the kidneys with the urine. Blood sugar levels decrease.
Through “calorie excretion,” body weight also decreases. In addition, blood pressure may also decrease. Several endpoint studies have also shown that some drugs from the SGLT2 inhibitor class can have a positive effect on the course of kidney disease (nephropathy) and heart failure and prevent premature mortality, and significantly reduce the risk of heart attack and death in patients with type 2 diabetes and prior cardiovascular disease (high to moderate evidence).
SGLT2 inhibitors do not increase the risk of hypoglycemia with monotherapy. Possible side effects include urinary tract and genital infections, fluid loss, skin rash and itching, dizziness, constipation and/or nausea, increased thirst and/or frequent urination, and diabetic ketoacidosis.

GFP-1 Receptor Agonists

These include such substances as Dulaglutide, Exenatide, Liraglutide, Ssemaglutide, Lixisenatide, and albiglutide. The acronym GFP-1 stands for “glucagon-like peptide-1” and describes a protein that is one of the gut hormones. GTP-1 is released in response to food intake and is involved in controlling sugar metabolism. It promotes the production of insulin by the pancreas and, at the same time, suppresses the hormone glucagon, an insulin antagonist. GFP-1 receptor agonists mimic the action of the gut hormone GFP-1. In this case, the feeling of satiety comes earlier, and a person loses weight.

In contrast to the other classes of substances listed above, most of the GFP-1 receptor agonists nowadays still have to be injected subcutaneously, i.e. into the subcutaneous fatty tissue. Patients can do this on their own once or twice a day or once a week.

These substances contribute in particular to weight loss. Current endpoint studies show that some GTP-1 receptor agonists may also reduce the risk of cardiovascular disease (CVD) and kidney disease (nephropathy) as well as premature mortality, especially in people with pre-existing heart disease (high to moderate evidence).

Gastrointestinal complaints such as nausea and bloating are common but often go away during treatment. Other typical side effects include, for example, skin rashes, headache, dizziness, fatigue, inflammation of the nose and throat and/or gallbladder, as well as increased enzyme levels, increased heart rate, and/or cardiac arrhythmias.

Glyxambi and the Pharmacological Properties of the Drug

Confirmed hypoglycaemic events – GLYXAMBI 10 mg/5 mg and GLYXAMBI 25 mg/5 mg.

	Trial 1275.1 (Add-on to Metformin)
	GLYXAMBI 10mg/5mg	GLYXAMBI 25mg/5mg	Empagliflozin 10mg	Empagliflozin 25mg	Linagliptin 5mg
Number of patients analysed, N (%) Patients with endpoint, N (%)	136(100.0) 3 (2.2)	137(100.0) 5 (3.6)	141 (100.0) 2 (1.4)	141 (100.0) 5 (3.5)	132(100.0) 3 (2.3)
	Trial 1275.1 (Treatment naive)
	GLYXAMBI 10mg/5mg	GLYXAMBI 25mg/5mg	Empagliflozin 10mg	Empagliflozin 25mg	Linagliptin 5mg
Number of patients analysed, N (%) Patients with endpoint, N (%)	136(100.0) 0 (0.0)	136 (100.0) 0 (0.0)	135(100.0) 4 (3.0)	135 (100.0) 1 (0.7)	135 (100.0) 1 (0.7)
	Trial 1275.9 (Add-on to metformin + Linagliptin 5 mg)
	Empagliflozin 10mg		Empagliflozin 25mg		Placebo
Number of patients analysed, N (%) Patients with endpoint, N (%)	112 (100.0) 0 (0.0)		110 (100.0) 3 (2.7)		110 (100.0) 1 (0.9)
	Trial 1275.10 (Add-on to metformin + Empagliflozin)
	Metformin + Empagliflozin 10 mg			Metformin + Empagliflozin 25 mg
	Linagliptin 5 mg		Placebo	Linagliptin 5 mg	Placebo
Number of patients analysed, N (%) Patients with endpoint, N (%)	126 (100.0) 0 (0.0)		128(100.0) 0 (0.0)	112 (100.0) 0 (0.0)	112 (100.0) 3 (2-7)

A strict diet and exercise are usually prescribed with the treatment of diabetes. This is because lifestyle changes will lead to the prevention of the risk of complications. If the whole set of recommendations does not help, the doctor prescribes medicines that involves the use of drugs specifically used for the treatment of type 2 diabetes. But again, you should keep in mind that they can only work in combination with exercise and diet therapy. It is not recommended for the treatment of type one diabetes.

The substance linagliptin was discovered in 2010, and clinical trials have proven that drugs based on it can significantly reduce blood sugar levels. It is involved in maintaining glucose at normal levels. When this substance was used as a mono drug, it turned out that its effectiveness is not worse than in combination with other drugs for the treatment of diabetes. Glyxambi-based medication is also capable of reducing fasting blood glucose levels and is particularly commonly used.

This drug has been extensively studied and used both on volunteers and patients with type 2 diabetes. Efficacy was achieved after the first week of treatment, the maximum concentration an hour and a half after ingestion.

Contraindications and Adverse Reactions

We would like to warn you that such drugs are prescribed strictly by an endocrinologist. The drug is selected by taking into account the clinical picture of the patient: age, the severity of feeling, diagnosis, concomitant chronic pathologies, blood glucose levels, and other data. Glyxambi drug class is contraindicated in a wide range of patients, first of all, it should not be taken if you are diagnosed with type 1 diabetes, also during pregnancy, lactation, children under 18, hypersensitivity to components; care should be taken in patients with pancreatitis, older people aged 80 and when used with other medications.

The drug also causes adverse reactions, though all of them are transient and practically do not require treatment cancellation. But still, if you feel uncomfortable with undesirable reactions, tell your doctor. The Glyxambi dosage may be chosen incorrectly, or the drug is not suitable for you, then your doctor will prescribe another drug.

One of the most severe and common consequences of diabetes mellitus is impaired renal function – nephropathy with developing renal failure. To some extent, this complication occurs in 40% of diabetics, it usually begins asymptomatically.

Liver disorders, especially fatty hepatosis, are also not uncommon among diabetic patients. In this case, Glyxambi is the only DPP4 inhibitor drug that the instructions allow use without restrictions. This is especially true for elderly patients with a high risk of hypoglycemia.

Starting to take Glyxambi, you can expect glycated hemoglobin to decrease by about 0.7%. When combined with Glyxambi, the results are better – about 0.95%. Feedback from doctors suggests that the drug is equally effective in patients with newly diagnosed diabetes and with a history of the disease of more than 5 years. Studies conducted over 2 years have proven that the effectiveness of the drug Glyxambi does not decrease over time.

After using Glyxambi there may be mild to severe side effects ranging from headaches to anxiety. When using Glyxambi, be sure to read the full list of the side effects of this medication.

Contraindications to the drug Glyxambi are diseases in which it is prohibited to take the drug. There may also be undesirable effects on the body when taking Glyxambi in amounts not prescribed in the instructions. In the event of symptoms of overuse, you should call an ambulance.

Storage and Transportation of Glyxambi

The drug should be stored away from children in the original container. The storage temperature range is 25 degrees Celsius. Store at 25 C in a safe place out of the reach of children.

Frequently Asked Questions

What Is Glyxambi?

Glyxambi is a treatment for type 2 diabetes. It is used as a dietary supplement.

What Is Glyxambi Used For?

The standard glyxambi dose of the drug is 10 mg per day, combined with 5 mg of empagliflozin in the morning, regardless of diet. If the body tolerates the medication well, the dosage of Glyxambi is increased to 25 mg.

Which Side Effect Can Glyxambi Cause?

• Upper respiratory tract infections;
• infection of the urinary tract;
• osmatic diuresis;
• dyslipidemia;
• episodes of nausea;
• skin rashes;
• genital fungus.