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Safety Profile

DURATION-3 Safety and Tolerability From the 3-year Clinical Trial

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Hypoglycemia

BYDUREON was associated with a low rate of hypoglycemia over 3 years

3-year exposure-adjusted rates of overall hypoglycemia
3-year exposure-adjusted rates of overall hypoglycemia
3-year exposure-adjusted rates of overall hypoglycemia

aMean insulin dose at 3 years, 39 IU/day.2

The risk of hypoglycemia is increased when BYDUREON is used in combination with Insulin Secretagogues or Insulin: Consider reducing the insulin secretagogues (eg, sulfonylureas) or insulin dose to reduce the risk of hypoglycemia.

  • No major hypoglycemic events* resulting in loss of consciousness or seizures were reported in either arm during the 3‑year study1

*Major hypoglycemia was classified as any episode with symptoms resulting in loss of consciousness or seizure that showed prompt recovery after administration of glucose, or documented blood glucose lower than 54 mg/dL, necessitating the assistance of another person because of severe impairment in consciousness or behavior.3

Abbreviation: mITT, modified Intent-ToTreat.

Rates of hypoglycemia at 26 weeks

Incidence of treatment-emergent minor hypoglycemia at 26 weeks
Incidence of treatment-emergent minor hypoglycemia at 26 weeks
Incidence of treatment-emergent minor hypoglycemia at 26 weeks

aMinor hypoglycemia was defined as a reported event that has symptoms consistent with hypoglycemia with a concomitant glucose <54 mg/dL and the patient was able to self-treat.

bMean insulin dose at 26 weeks was 31 IU/day.2

The risk of hypoglycemia is increased when BYDUREON is used in combination with Insulin Secretagogues or Insulin: Consider reducing the insulin secretagogues (eg, sulfonylureas) or insulin dose to reduce the risk of hypoglycemia.

  • No major hypoglycemic events were reported in either arm

Hypoglycemia that results in loss of consciousness, seizure, or coma (or other mental status change consistent with neuroglycopenia in the judgment of the investigator or physician), which resolves after administration of glucagon or glucose, or requires third-party assistance to resolve because of severe impairment in consciousness or behavior. Patients were to have a concomitant glucose value of <54 mg/dL.


Most Common Adverse Events

Adverse events over 3 years

Adverse events occurring in ≥5% of patients with BYDUREON over 3 years
Adverse events occurring in ≥5% of patients with BYDUREON over 3 years
Adverse events occurring in ≥5% of patients with BYDUREON over 3 years

aMean insulin dose at 3 years was 39 IU/day.2

bComposite of terms for injection-site adverse events: induration, injection-site erythema, injection-site extravasation, injection‑site hematoma, injection-site induration, injection-site mass, injection-site nodule, injection-site pain, injection-site pruritus, injection-site reaction, and injection-site swelling.

Adverse events over 26 weeks

Most common treatment-emergent adverse events at 26 weeks
Most common treatment-emergent adverse events at 26 weeks
Most common treatment-emergent adverse events at 26 weeks

aMean insulin dose at 26 weeks was 31 IU/day.2


Withdrawals

Designed to be patient-friendly.

BYDUREON Pen

Designed to be patient-friendly.

BYDUREON Pen

Designed to be
patient-friendly.

Patient Support

Patient Support

Free resources for your patients on BYDUREON.

Patient Support

Free resources for your patients on BYDUREON.