print_label | resize_label

Clinical Efficacy

BYETTA + Insulin Glargine

Select a category or scroll to learn more.



Study design

Study design

Adult patients with type 2 diabetes with inadequate control 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/dL1 adapted from the Treat-to-Target algorithm.1,2 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 insulin glargine titration algorithm.


A1C reduction

A1C reduction

In a 30-Week Placebo-Controlled Trial in Combination with Insulin Glargine With or Without Metformin and/or Thiazolidinediones

Mean change in A1C at 30 weeks

Abbreviations: BL, baseline; ITT, intent to treat; LS, least squares.

aBYETTA 5 mcg BID for 1 month followed by 10 mcg BID for the remainder of the 30-week study.

Mean change in A1C at 30 weeks

Abbreviations: BL, baseline; ITT, intent to treat; LS, least squares.

aBYETTA 5 mcg BID for 1 month followed by 10 mcg BID for the remainder of the 30-week study.

  • BYETTA BID plus titrated insulin glargine reduced A1C by -1.7% vs -1.0% for placebo plus titrated insulin glargine.1
  • Insulin dosage increased from baseline in both groups, but the increase was greater in the placebo+insulin glargine group (+20 Units/day [CI, 16-24 U/day]) vs exenatide group (+13 U/day [CI, 9-17 U/day]).1

VIEW SAFETY PROFILE

Contraindictions

  • BYETTA is contraindicted in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.

Select Important Safety Information: Warnings and Precautions

  • Never Share a BYETTA Pen Between Patients: Pen-sharing poses a risk for transmission of blood-borne pathogens, even if the needle is changed.
  • Pancreatitis: Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation and dose increases of BYETTA, observe patients carefully for pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, BYETTA should be discontinued promptly and should not be restarted if pancreatitis is confirmed.
  • 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.


Weight loss

Additional benefit of weight loss*

In the same clinical trial, BYETTA also provided the additional benefit of weight loss.

Mean weight change at 30 weeks

Abbreviation: BL, baseline.

BYETTA is not indicated for weight loss.

*Weight reduction was a secondary end point

Mean weight change at 30 weeks

Abbreviation: BL, baseline.

BYETTA is not indicated for weight loss.

*Weight reduction was a secondary end point

With BYETTA 10 mcg plus titrated insulin glargine, 57% of patients achieved an A1C of <7% compared to 30% of patients receiving placebo plus titrated insulin glargine at 30 weeks (secondary endpoint).

VIEW SAFETY PROFILE

Select Important Safety Information: Warnings and Precautions

  • Renal Impairment: Should not be used in patients with severe renal impairment or end-stage renal disease. Use with caution in patients with renal transplantation or when initiating or escalating the dose in patients with moderate renal failure. Postmarketing reports of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure, and acute renal failure, sometimes requiring hemodialysis and kidney transplantation.
  • Gastrointestinal Disease: Because exenatide is commonly associated with gastrointestinal adverse reactions, BYETTA is not recommended in patients with severe gastrointestinal disease (eg, gastroparesis).
  • Immunogenicity: Patients may develop antibodies to exenatide. In 3 registration trials, antibody levels were measured in 90% of patients, with up to 4% of patients having high-titer antibodies and attenuated glycemic response. If worsening of or failure to achieve adequate glycemic control occurs, consider alternative antidiabetic therapy.
  • Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions (eg, anaphylaxis and angioedema). If this occurs, patients should discontinue BYETTA and other suspect medications and promptly seek medical advice.
  • Macrovascular Outcomes: No clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.


Clinical summary

Clinical summary

For appropriate adult patients with type 2 diabetes uncontrolled on insulin glargine with or without metformin and/or TZD in addition to diet and exercise

In the 30-week clinical study, patients on BYETTA experienced the following:

  • Significantly greater A1C reduction of 1.7% compared to 1.0% for titrated insulin glargine alone.*
  • Helped 57% of patients get to an A1C < 7% compared to 30% of patients on insulin glargine alone, and provided the potential for weight loss.
  • Rate of hypoglycemia for BYETTA plus titrated insulin glargine vs placebo plus titrated insulin glargine was 24.8% vs 29.5%, respectively.
  • Nausea, the most common adverse event, was 41% for BYETTA vs 8% for Placebo+insulin glargine.

BYETTA+insulin glargine, mean baseline A1C, 8.3%; placebo+insulin glargine, mean baseline A1C, 8.5%.

BYETTA is not indicated for weight loss.

*Weight reduction was a secondary end point

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