In a clinical study done by Biocon, the adverse events for BASALOG One were found to be similar in nature, frequency and severity as compared to the reference product (Lantus).
Hypoglycaemic events were the most common adverse events in both the treatment groups. Apart from hypoglycaemia, pyrexia was the next most common adverse event with 3 events in each study arm. Retinal adverse events reported in this study were comparable between the treatment groups. The abnormalities in the laboratory parameters were comparable between the 2 study arms and all of them were considered not clinically significant. Antibodies against BASALOG One were observed with the same frequency as compared to the reference product (Lantus).
The following data for adverse events is summarised from the publicly available information of Lantus.
Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
The following related adverse reactions from clinical investigations are listed as follows by sytem organ class and in order of decreasing incidence: Side effects reported very commonly (>1/10): Metabolism and nutrition disorders: hypoglycaemia.
Side effects reported commonly (>1/100 to <1/10): Skin and subcutaneous tissue disorders: lipohypertrophy. General disorders and administration site conditions: injection site reactions.
Side effects reported uncommonly (>1/1000 to <1/100): Skin and subcutaneous tissue disorders: lipoatrophy.
Side effects reported rare (>1/10,000 to <1/1,000): Immune system disorders: Allergic reactions.
Eye disorders: visual impairment, retinopathy.
General disorders and administration site conditions: Oedema.
Side effects reported very rare (<1/10,000): Nervous system disorders: Dysgeusia.
Musculoskeletal and connective tissue disorders: myalgia.
Metabolism and Nutrition Disorders: Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episodes may be life-threatening. In many patients, the signs and symptoms of neuroglycopaenia are preceded by signs of adrenergic counter regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Immune System Disorders: Immediate-type allergic reactions to insulin glargine are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio oedema, bronchospasm, hypotension and shock, and may be life threatening.
Insulin glargine administration may cause insulin glargine antibodies to form. In clinical studies, antibodies that cross-react with human insulin and insulin glargine were observed with the same frequency in both NPH-insulin and insulin glargine treatment groups. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Eye Disorders: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensive of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Skin and Subcutaneous Tissue Disorders: As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.
General Disorders and Administration Site Conditions: Injection site reactions include redness, pain, itching, hives, swelling, or inflammation. Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks. Rarely, insulin glargine may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Paediatric Population: In general, the safety profile for children and adolescents (18 years of age) is similar to the safety profile for adults. The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (18 years of age) than in adults. No safety data from clinical studies are available in children below 2 years of age.