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Safety Profile

Safety Profile

BYETTA + Insulin Glargine

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Rates of hypoglycemia

Rates of hypoglycemia

rates of hypoglycemia in the 30-week trial
Rates of hypoglycemia in the 30-week trial

In the 30-week registration study of BYETTA (exenatide) versus placebo added to titrated insulin glargine with or without metformin and/or TZD, patients with an A1C = 8% were instructed to decrease their insulin glargine dose by 20%; patients with an A1C > 8% maintained their current insulin dose.

aA hypoglycemic episode was recorded if a patient reported symptoms of hypoglycemia with or without a blood glucose value consistent with hypoglycemia. Severe hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a documented blood glucose value, 54 mg/dl or prompt recovery after treatment for hypoglycemia.

bConsider reducing the dose of insulin glargine in patients at increased risk for hypoglycemia.

  • In the 30-week study, rates of hypoglycemia for BYETTA (exenatide) injection were 24.8% vs 29.5% for Placebo+insulin glargine when either was added to titrated insulin glargine with or without metformin and/or TZD

Rates of discontinuation

  • The most frequently reported adverse reactions leading to withdrawal for BYETTA-treated patients were nausea (5.1%) and vomiting (2.9%). No placebo-treated patients withdrew due to nausea or vomiting
  • 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

adverse reactions in the 30-week trial
Most common adverse reactions in the 30-week trial

aData are from the 30-week registration study of BYETTA with insulin glargine (Lantus) added to titrated insulin glargine.

  • aPatients with type 2 diabetes on insulin glargine alone or in combination with metformin and/or TZD were enrolled in a 30-week, randomized, double-blind, placebo-controlled clinical study to receive either BYETTA (exenatide) injection (n = 137) or placebo (n = 122) in addition to titrated insulin glargine. In both arms, under investigator guidance, insulin was titrated to achieve a targeted fasting glucose level of < 100 mg/dL using the Treat-to-Target algorithm. Upon adding BYETTA to insulin glargine, patients with an A1C = 8% were instructed to decrease their insulin glargine dose by 20%; patients with an A1C > 8% maintained their current insulin dose. Patients receiving BYETTA were titrated from the 5-mcg dose to the 10-mcg dose after the first 4 weeks.1 Please see full Prescribing Information for full dosing algorithm

Nausea

  • Inform patients of the potential side effects, including mild-to-moderate nausea, upon initiation of BYETTA, that decrease over time in most patients
  • Inform patients that persistent severe abdominal pain, with or without vomiting, is a symptom of acute pancreatitis. Instruct patients to promptly discontinue BYETTA and contact their healthcare provider if persistent severe abdominal pain occurs