Exenatide Added to Updated Consensus Algorithm

Byetta Clinical Data

BYETTA achieves multiple benefits by mimicking many of the actions of GLP-1 (glucagon-like peptide-1), a naturally occurring incretin hormone secreted from the intestines in response to food intake.

At 30 weeks, in an open label, active-controlled comparator trial (N = 147), BYETTA delivered powerful A1C reductions with weight loss*¹

After 3 years, in an open-label extension analysis of registration trials (N = 217), most patients sustained glycemic improvements with weight loss²

Up to 4X as many patients reached an A1C ≤7% when BYETTA was added compared to patients on oral therapy alone (metformin or a thiazolidinedione ± metformin)^3,4

*BYETTA is not indicated for the management of obesity, and weight change was a secondary endpoint in clinical trials.

BYETTA clinical study design

BYETTA was evaluated in three 30-week, double-blind, placebo-controlled clinical trials in patients with type 2 diabetes whose glycemic control was inadequate with metformin alone, a sulfonylurea alone, or metformin in combination with a sulfonylurea. There was no washout period prior to initiating BYETTA, and patients were not required to follow any specified diet or exercise plan.

A total of 1446 patients were randomly assigned to receive BYETTA 5 mcg BID, BYETTA 10 mcg BID, or placebo BID in addition to their existing oral antidiabetic agent following a 4-week placebo lead-in period
All patients assigned to BYETTA began a treatment initiation period with 5 mcg BID for 4 weeks. After 4 weeks, those patients either continued to receive BYETTA 5 mcg BID or had their dose increased to 10 mcg BID
To assess the durable effects of BYETTA, an open-label extension study of patients from the placebo-controlled trials was conducted through 3 years¹

Indication

BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.

Important Safety Information

Precautions:

BYETTA is not a substitute for insulin in insulin-requiring patients. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Patients should be observed for signs and symptoms of acute pancreatitis (persistent severe abdominal pain which may be accompanied by vomiting). If pancreatitis is suspected, BYETTA and other potentially suspect drugs should be discontinued. Resuming treatment with BYETTA is not recommended if pancreatitis is confirmed and an alternative etiology for the pancreatitis has not been identified.
Patients should be observed for signs and symptoms of hypersensitivity reactions.
BYETTA is not recommended for use in patients with end-stage renal disease, severe renal impairment, or severe gastrointestinal disease.
Patients should be observed for signs of altered renal function, including those who are taking concomitant agents known to affect renal function/hydration status, such as diuretics, ACE inhibitors and NSAIDs, or those experiencing significant vomiting and/or diarrhea, which may lead to dehydration.
Patients receiving BYETTA with a sulfonylurea have an increased risk of hypoglycemia. To reduce the risk of hypoglycemia, clinicians may consider reducing the sulfonylurea dose.

Drug Interactions:

The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered drugs, so it should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.
Medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, should be taken at least 1 hour before BYETTA injection. If such drugs are to be administered with food, they should be taken with a meal or snack when BYETTA is not administered.

Adverse Reactions:

The most common adverse events associated with BYETTA were nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, and dyspepsia.

For complete safety profile and other important prescribing considerations, see the Prescribing Information.

References

Data on file, Amylin Pharmaceuticals, Inc. and Lilly USA, LLC.
Klonoff DC, Buse JB, Nielsen LL, et al. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008;24(1):275-286.
DeFronzo RA, Ratner RE, Han J, et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005;28(5):1092-1100.
Zinman B, Hoogwerf BJ, Duran Garcia S, et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007;146(7):477-485.