Type 1 diabetes adverse events
This trial was not designed to evaluate the relative safety between BASAGLAR and Lantus products (approved in the US or outside the US), and comparator adverse event rates are not an adequate basis for comparison of rates between the products.
BASAGLAR vs Lantus products (approved in the US or outside the US): severe symptomatic hypoglycemia over 52 weeks of treatment7
BASAGLAR + Insulin lispro
Lantus products† + Insulin lispro
Hypoglycemia was the most commonly observed adverse reaction in patients using insulin, including BASAGLAR. Hypoglycemia was defined as blood glucose ≤3.9 mmol/L (≤70 mg/dL) or a sign or symptom associated with hypoglycemia. Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia that required assistance of another person, and was associated with either blood glucose levels below 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.1,7
Rates of reported hypoglycemia depend upon the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic factors. For these reasons, comparing rates of hypoglycemia in clinical trials for BASAGLAR with the incidence of hypoglycemia for other products may be misleading, and may not be representative of hypoglycemia rates that will occur in clinical practice.