print_label | resize_label

Safety Profile

Safety Profile

 BYETTA vs insulin lispro 

Select a category or scroll to learn more.


Rates of hypoglycemia

Rates of hypoglycemia

Incidence of hypoglycemia by category over 30 weeks
  • Data represent the intent-to-treat population (all patients who were randomized and received at least 1 dose of study medication).
  • Major hypoglycemia was defined as symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure that showed prompt recovery following glucagon or glucose administration or documented hypoglycemia (blood glucose <54 mg/dL) and reguired the assistance of another person because of severe impairment in consciousness or behavior; minor hypoglycemia was defined as any patient experience of a sign or symptom associated with hypoglycemia and a blood glucose of <54 mg/dL that was either self-treated or resolved on its own.
Incidence of hypoglycemia by category over 30 weeks
Rates of hypoglycemia in the 30-week trial
Rates_Of_Hypoglycemia_Chart
  • Lower incidences of minor hypoglycemia (BYETTA (exenatide) injection, 30%; insulin lispro, 41%) and major hypoglycemia (BYETTA, 0.6%; insulin lispro, 2.2%) were observed1
  • In a separate 30-week clinical study in which patients received either BYETTA or placebo in addition to titrated insulin glargine (with or without metformin and /or thiazolidinedione [TZD]), rates of hypoglycemia were 24.8% for BYETTA vs 29.5% for placebo
  • Hypoglycemia: Increased risk of hypoglycemia when used in combination with a sulfonylurea (SU) or when used with a glucose-independent insulin secretagogues (eg, meglitinides). Clinicians may consider reducing the SU dose in patients receiving BYETTA to reduce the risk of hypoglycemia. When used with insulin, evaluate and consider reducing the insulin dose in patients at increased risk of hypoglycemia


Adverse events

Adverse events

Treatment-emergent adverse events (5%) over 30 weeks

Data represent the intent-to-treat population.

Most common adverse reactions in the 30-week trial

Data represent the intent-to-treat population.

Data represent the intent-to-treat population.

  • The discontinuation rates due to treatment-emergent adverse events (BYETTA, 5.4%; insulin lispro, 2.6%) and percentage of patients with at least 1 serious adverse event (BYETTA, 5.7%; insulin lispro, 7.4%) were similar between groups1

Nausea

  • Inform patients of the potential side effects, including mild-to-moderate nausea, upon initiation of BYETTA, which decrease over time in most patients

Pancreatitis

  • After initiation of BYETTA, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting). If pancreatitis is suspected, BYETTA should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, BYETTA should not be restarted
  • Reference: 1. Diamant M, Nauck MA, Shaginian R, et al; for the BYETTA vs mealtime insulin Study Group. Glucagon-like peptide-1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014;37(10):2763-2773.