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General: Glaritus is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases.
In case of insufficient glucose control or a tendency to hyper-or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Patients must be instructed in the skills necessary for the self-management of diabetes, such as blood sugar monitoring, proper injection technique, measures for recognising and managing reduced or increased blood sugar levels (hypo-or hyperglycaemia) as described as follows. In addition, they must learn how to handle special situations such as skipped, inadequate or increase insulin doses, inadequate food intake or missed meals. Moreover, patients and their relatives must learn how to recognize the signs and symptoms of hypo-or hyperglycaemia, what corrective actions need to be taken and when they must speak with their doctor.
Hypoglycaemia: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed. Due to more sustained basal insulin supply with Glaritus, less nocturnal but more early morning hypoglycaemia can be expected.
Hypoglycaemia is more likely to occur at the start of insulin treatment, following transfer to a different insulin preparation, where metabolic control is unstable, or in severe kidney or liver diseases.
Symptoms that may indicate the onset of hypoglycaemia may be, e.g., sweating, clammy skin, anxiety, fast heartbeat, high blood pressure, palpitations and irregular heartbeat, chest pain (angina pectoris). In many patients, these signs and symptoms often develop before those of a low sugar level in the brain. The latter include headache, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensation (paraesthesiae) numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after oneself, convulsions, and loss of consciousness.
The initial symptoms pointing to the onset of hypoglycaemia ("warning symptoms") may change be milder, or be entirely absent, e.g., in the following circumstances: Markedly improved blood sugar control, slow-developing hypoglycaemia, advanced age, a certain type of nervous disease (autonomic neuropathy), long-standing diabetes, a psychiatric illness, or concurrent use of other medicines [see Interactions]. In such circumstances severe hypoglycaemia (and even loss of consciousness) may develop without the patients noticing it. Affected patients should try to keep familiar at all times with their individual warning symptoms. More frequent blood sugar testing can help to identify mild hypoglycaemic episodes which otherwise might be overlooked. Patients not confident of recognizing their warning symptoms should avoid situations (e.g. driving) that might result in danger to themselves or others.
As with all insulins, particular caution should be exercised, and intensified blood glucose monitoring is advisable, in patients in whom hypoglycaemic episodes might be of particular clinical relevance. For example, these could be patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac of cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
Patients should be
aware of circumstances where warning symptoms of hypoglycaemia are diminished.
The warning symptoms of hypoglycaemia may be changed, be less pronounced or be
absent in certain risk groups. These include patients: In whom glucaemic control
is markedly improved; in whom hypoglycaemia develops gradually; who are elderly;
after transfer from animal insulin to human insulin; in whom an autonomic
neuropathy is present; with a long history of diabetes; suffering from
psychiatric illness; receiving concurrent treatment with certain other
medicinal products.
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognized (especially nocturnal) episodes of hypoglycaemia must be considered.
Compliance of the
patient to the dosage and dietary regimen, correct insulin administration and
awareness of hypoglycaemia symptoms are essential to reduce the risk of
hypoglycaemia. Presence of factors increasing the susceptibility to
hypoglycaemia require particularly close monitoring and may necessitate dose
adjustment. These include: Change in the injection area; improved insulin
sensitivity (by e.g., removal of stress factors); unaccustomed, increased or
prolonged-physical activity; intercurrent illness (e.g. vomiting, diarrhoea); inadequate
food intake; missed meals; alcohol consumption; certain uncompensated endocrine
disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical
insufficiency); concomitant treatment with certain other medicinal products.
A hypoglycaemic attack can be corrected by immediately taking sugar, e.g., in the form of glucose, sugar cubes or sugar-sweetened beverages. In this regard, note that food or beverages containing artificial sweeteners (e.g. diet foods and drinks) are not suitable. Subsequently, some food having a long-acting blood-sugar-raising effect (e.g. bread) should be taken. The long action of Glaritus may delay recovery from hypoglycaemia. If hypoglycaemia recurs, another 10-20 g of sugar should be taken. If a hypoglycaemia attack cannot be corrected of if it recurs, speak to a doctor immediately.
Carry at least 20 g of sugar at all times, together with some information identifying the patient as a diabetic. Inability to swallow or unconsciousness will make necessary injections of glucose solution of glucagons (a medicine increasing blood sugar), even where the presence of hypoglycaemia is uncertain. Following intake of glucose, hypoglycaemia should be conformed by means of blood sugar testing.
Hyperglycaemia may
occur under certain circumstances. These include: Omission of reduction of
injections or decrease in insulin effectiveness (e.g. due to incorrect storage);
pen malfunction; decreased physical activity, stress situations (emotional
distress, excitement), injuries, operations, feverish illnesses or certain
other diseases; concurrent use of other medicines [see Interactions].
Thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat and high concentrations of sugar and ketone bodies in the urine may be signs of hyperglycaemia. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious metabolic condition (ketoacidosis) resulting from lack of insulin. Blood sugar testing or tests for ketones in urine must be carried out as soon as any such symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
Intercurrent illness: Intercurrent illness requires intensified metabolic monitoring. In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrate on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
Hepatic Impairment: In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Renal Impairment: In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.
Obesity: Subgroup analyses based on BMI in reported controlled clinical studies, did not show differences in safety and efficacy between insulin glargine and NPH.
Use in Children: The safety and effectiveness of insulin glargine have been established in pediatric patients aged >2 years in reported clinical studies. The safety and effectiveness of insulin glargine in pediatric patients younger than 2 years of age have not been established.
Use in the Elderly (≥65 years old): In the geriatric, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
