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Safety Profile

6-Year Safety Data From the Open-Label Extension of DURATION-1

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Over 6 years, no unexpected safety findings were reported1

DURATION-1 was a 30-week, open-label, comparator-controlled study (N = 295) in which adult patients with type 2 diabetes who were inadequately controlled on diet and exercise with or without oral antidiabetic medications (metformin, sulfonylurea, thiazolidinedione, or any combination) were randomized to receive either BYDUREON 2 mg QW or exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID. After 30 weeks, all patients in both arms were given the option to continue or switch to treatment with BYDUREON in an open-label extension. Of 295 patients randomized to either the BYETTA® (exenatide) injection or BYDUREON arm in the 30-week controlled phase, 258 opted to continue receiving or switch to BYDUREON. Of these, 127 (43%) completed 6 years of treatment. Among 6‑year completers, 56.7% added a new glucose-lowering medication at some point during the 6 years of treatment.1,2


Hypoglycemia1

3-year exposure-adjusted rates of overall hypoglycemia
  • No cases of major hypoglycemia* were reported
  • Cases of minor hypoglycemia were largely dependent on background therapy with most events occurring with concomitant sulfonylurea

– 28.6% and 8.1% of patients with and without sulfonylurea at screening, respectively, reported ≥1 event

*Major hypoglycemia was defined as loss of consciousness, seizure, or coma, which resolved after administration of glucagon or glucose or required third-party assistance to resolve, and a glucose concentration of less than 54 mg/dL (3 mmol/L).2

Incidence of treatment-emergent minor hypoglycemia at 26 weeks

Minor hypoglycemia was defined as patients reporting symptoms consistent with hypoglycemia and a plasma glucose concentration of less than 54 mg/dL (3 mmol/L).2


Most Common Adverse Events

Adverse events over extension period (week 30 to 6 years) and controlled period (week 0 to 30)

Adverse events occurring in ≥5% of patients with BYDUREON over 3 years
DURATION-1 treatment-emergent adverse events
Adverse events occurring in ≥5% of patients with BYDUREON over 3 years

a1.8% of AEs were not coded in this interim data analysis and are not included in total AEs.

bAEs were assessed for the ITT population who continued into the extension phase starting at week 30.

cAEs were assessed for the ITT population of the 30‑week controlled portion of the study (N = 295), defined as all randomized patients who received at least 1 injection of exenatide.

Most common treatment-emergent adverse events at 26 weeks
  • Nausea (mostly mild) decreased after the initial controlled period1

 From 0.85 (weeks 0 to 30) to 0.08 events/year of patient exposure (week 30 to year 6)


Withdrawals1

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.