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In the study, 44.1 percent of patients receiving BYDUREON, compared with 11.4 percent of those treated with insulin detemir, met the primary composite endpoint of A1C less than or equal to 7 percent and weight loss greater than or equal to 2.2 pounds (P less than 0.0001) at 26 weeks. Treatment with BYDUREON also resulted in greater improvement in A1C (-1.3 percentage points) than insulin detemir (-0.88 percentage points). A1C is a measure of average blood sugar over three months. Patients receiving BYDUREON lost an average of 5.9 pounds, while those receiving insulin detemir gained an average of 1.8 pounds, resulting in a treatment difference of 7.7 pounds.
"In this study, treatment with BYDUREON resulted in a significantly greater proportion of patients achieving target glucose levels compared to insulin detemir and was associated with weight loss and a lower risk of hypoglycemia," said
There were no events of major hypoglycemia in either group. Gastrointestinal-related and injection-site-related adverse events occurred more frequently with BYDUREON than with insulin detemir.
Study Details
This multicenter, open-label, parallel-arm study conducted in the
About BYDUREON™ (exenatide extended-release for injectable suspension)
BYDUREON is the first and only once-weekly medicine to be approved by the
BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.
BYDUREON and BYETTA both contain the same active ingredient, exenatide, and therefore should not be used together. BYDUREON is not insulin and should not be taken instead of insulin. BYDUREON is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYDUREON is not recommended for use in children. It is not known if BYDUREON is safe and effective in people with a history of pancreatitis or severe kidney problems. See important safety information below. Additional information about BYDUREON is available at http://www.BYDUREON.com.
Important Safety Information for BYDUREON™ (exenatide extended-release for injectable suspension)
In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some tumors were cancers. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. BYDUREON should not be used if there is a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2.
Based on post-marketing data, exenatide has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation of BYDUREON.
The risk of getting low blood sugar is higher if BYDUREON is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of sulfonylurea may need to be lowered while BYDUREON is used. BYDUREON should not be used in people who have or had severe kidney problems and may cause or worsen problems with kidney function, including kidney failure. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYDUREON, which may lead to worsening or failure to achieve adequate glycemic control. Severe allergic reactions can happen with BYDUREON. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYDUREON or any other antidiabetic drug.
The most common side effects with BYDUREON include nausea, diarrhea, headache, vomiting, constipation, itching at injection site, a small bump (nodule) at the injection site and indigestion. Nausea most commonly happens when first starting BYDUREON, but may become less over time.
These are not all the side effects from use of BYDUREON. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.
For additional important safety information about BYDUREON, please see the full Prescribing Information (www.BYDUREON.com/pi) and patient Medication Guide (www.BYDUREON.com/mg).
About BYETTA® (exenatide) injection
BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the
BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. It can also be used with metformin, a sulfonylurea, a thiazolidinedione or Lantus® (insulin glargine), which is a long-acting insulin.
BYETTA is not insulin and should not be taken instead of insulin. BYETTA should not be taken with short- and/or rapid-acting insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been studied in patients with a history of pancreatitis. Other antidiabetic therapies should be considered for these patients.
BYETTA provides sustained A1C control with potential weight loss (BYETTA is not a weight-loss product). BYETTA was approved in the U.S. in
Important Safety Information for BYETTA® (exenatide) injection
Based on post-marketing data, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation or dose escalation of BYETTA.
The risk of getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of sulfonylurea or insulin may need to be lowered while BYETTA is used. BYETTA should not be used in people who have severe kidney problems and may cause or worsen problems with kidney function, including kidney failure. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYETTA. Patients who develop high titers to exenatide could have worsening or failure to achieve adequate glycemic control. Severe allergic reactions can happen with BYETTA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.
The most common side effects with BYETTA include nausea, vomiting, diarrhea, feeling jittery, dizziness, headache, acid stomach, constipation and weakness. Nausea most commonly happens when first starting BYETTA, but may become less over time.
These are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.
For additional important safety information about BYETTA, please see the full Prescribing Information (www.BYETTA.com/pi) and patient Medication Guide (www.BYETTA.com/mg).
About
About
Forward-Looking Statement
This press release contains forward-looking statements about Amylin and
BYETTA is a registered trademark and BYDUREON is a trademark of
Source:
Media contacts:
Amylin
Alice Izzo
Phone: (858) 642-7272
Cell: (858) 232-9072
Email: alice.izzo@amylin.com
or
Alkermes
Rebecca Peterson
Phone: (781) 609-6378
Cell: (617) 899-2447
Email: rebecca.peterson@alkermes.com