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Safety Profile

DURATION-5 Safety and Tolerability From the 24‑week Clinical Trial

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Hypoglycemia

Incidence and rate of treatment-emergent minor hypoglycemia from a 24-week clinical trial
Incidence and rate of treatment-emergent minor hypoglycemia from a 24-week clinical trial
Incidence and rate of treatment-emergent minor hypoglycemia from a 24-week clinical trial

The risk of hypoglycemia is increased when BYDUREON is used in combination with a sulfonylurea or other glucose-independent secretagogues (eg, meglitinides). Clinicians may consider reducing the sulfonylurea dose.

In the 24-week, comparator-controlled trial of BYDUREON vs BYETTA used as an add-on to metformin, a sulfonylurea, a TZD, or a combination of any 2 of these oral antidiabetic agents:

  • There were no reports of major hypoglycemia* in either treatment arm
  • The incidence of minor hypoglycemia without concomitant sulfonylurea was 0.0% in both arms

In the DURATION-1 trial, the incidence of hypoglycemia with concomitant sulfonylurea was 14.5% and 15.4%, respectively; without concomitant sulfonylurea, 0.0% vs 1.1%, respectively, over 30 weeks.

*Hypoglycemia that results in the 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.

Reported event that has symptoms consistent with hypoglycemia with a concomitant glucose value of <54 mg/dL, and the patient was able to self-treat.

30-Week Monotherapy or as Add-On to Metformin, a Sulfonylurea, a Thiazolinedione, or Combination of Oral Agents Trial.


Most Common Adverse Events

Less than half the incidence of nausea compared to BYETTA over 24 weeks

Most common treatment-emergent adverse events from a 24-week clinical trial
Most common treatment-emergent adverse events from a 24-week clinical trial
Most common treatment-emergent adverse events from a 24-week clinical trial
  • Nausea was the most common adverse reaction associated with initiation of treatment with BYDUREON, and it usually decreased over time
  • Inform patients that persistent severe abdominal pain, with or without vomiting, is a symptom of acute pancreatitis. Instruct patients to promptly discontinue BYDUREON and contact their healthcare provider if persistent severe abdominal pain occurs
  • In the DURATION-1 trial, some of the most common adverse events for BYDUREON vs BYETTA were nausea (27% vs 33.8%), diarrhea (16.2% vs 12.4%), and vomiting (10.8% vs 18.6%) over 30 weeks


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.