DURATION-6 Top-Line Study Results Announced
This open-label 26-week, multicenter clinical study compared BYDUREON (2 mg weekly) to Victoza administered at the maximum approved dose of 1.8 mg daily. The study was designed to measure A1C, an assessment of average blood sugar, and to evaluate safety and tolerability.
Results showed that patients receiving BYDUREON experienced a reduction in A1C of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza. BYDUREON did not meet the pre-specified primary endpoint of non-inferiority to Victoza.
More than 85 percent of patients in both treatment arms completed the study. Gastrointestinal adverse events occurred more frequently among Victoza patients (nausea reported among 20 percent of patients, vomiting 11 percent, diarrhea 13 percent) compared with BYDUREON patients (nausea 9 percent, vomiting 4 percent, diarrhea 6 percent). Injection site nodule occurred more frequently among BYDUREON users (10 percent) compared with Victoza users (1 percent). There were no major hypoglycemia events in either treatment group.
Further evaluation of this data set is underway and, when complete, the companies plan to submit the full study results for publication.
"While this study did not meet its primary endpoint, these results reinforce the important role of GLP-1 receptor agonists in the treatment of type 2 diabetes," said
BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which has been available in the U.S. since
The New Drug Application for BYDUREON was submitted to the
DURATION-6 is the sixth in a series of studies comparing BYDUREON to other type 2 diabetes medications. The 26-week, head-to-head, open-label, superiority study enrolled approximately 900 patients in 19 countries outside the U.S. with type 2 diabetes who were not achieving adequate A1C control with diet and exercise in conjunction with metformin, a sulfonylurea, metformin plus a sulfonylurea or metformin plus Actos® (pioglitazone HCI). Patients had an average type 2 diabetes diagnosis of more than eight years. The patients were randomized to receive subcutaneous injection of either BYDUREON (2 mg, once per week) (n=461) or Victoza (forced titration to 1.8 mg, once per day) (n=451). The primary endpoint was reduction in A1C, while secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health and safety and tolerability.
Diabetes affects nearly 26 million people in the U.S. and an estimated 285 million adults worldwide.(i, ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs approximately
According to the
About BYETTA® (exenatide) injection
BYETTA was the first 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. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not currently recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been studied in people who have pancreatitis.
BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, 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. The risk for getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. BYETTA should not be used in people who have severe kidney problems, and should be used with caution in people who have had a kidney transplant. 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. Severe allergic reactions can happen with BYETTA.
The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. 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.
About Amylin, Lilly and
Amylin, Lilly and
Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
This press release contains forward-looking statements about Amylin, Lilly and
BYDUREON™ and BYETTA® are trademarks of
(i) Diabetes Statistics.
(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010. Accessed
(iii) Direct and Indirect Costs of Diabetes in
(iv) Saydah SH, Fradkin J and Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.
(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.
(vi) Nutrition Recommendations and Interventions for Diabetes: a position statement of the
(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.
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