In the controlled portion of the open-label study, patients received
exenatide once weekly or BYETTA® (exenatide) injection for 30
weeks, followed by 74 weeks of treatment with exenatide once weekly for
all patients during an open-ended assessment period. Significant
reductions in A1C of 1.7 percent and fasting plasma glucose (FPG) of 40
mg/dL were maintained after two years of treatment. Sixty-five percent
of patients achieved an A1C of 7 percent or less. (A1C of less than 7
percent is the target for good glucose control as recommended by the
“These two-year DURATION-1 data showed that maintenance of steady state concentrations of exenatide may result in sustained improvements in glycemic control, with potential weight loss,” said Orville G. Kolterman, M.D., senior vice president of research and development at Amylin. “In DURATION-1, exenatide once weekly has been shown to provide superior glycemic control, with weight loss, compared to BYETTA. If approved, this therapy could fill an important unmet need for treating patients with type 2 diabetes with just one dose per week.”
Study Design and Findings
The study enrolled 295 patients, with nearly 75 percent completing the two years of treatment. Baseline characteristics for these patients were: A1C 8.2±1.0%, FPG 168±43 mg/dL, body weight 223±41 pounds, BMI 34.8±4.8 kg/m2, diabetes duration 7.1±5.3 years. Significant improvements in both A1C [-1.7±0.1%] and FPG [-40±3 mg/dL] were maintained after two years of treatment, body weight was significantly reduced [-5.8±1.2 pounds], serum lipid profiles were significantly improved [total cholesterol -8.6±2.8 mg/dL; LDL cholesterol -4.5±2.2 mg/dL; triglycerides -15±3 percent], and there was a significant reduction in SBP [-3.0±1.0 mmHg for all participants and -9.4±1.5 mmHg for those with abnormal baselines].
Safety Profile
Nausea was the most common event during the 30-week treatment period and decreased over time, occurring in 12 percent of patients during the 74-week assessment period when all patients were receiving exenatide once weekly. No severe hypoglycemia was observed. The safety profile of patients treated in this study was consistent with the previously reported profiles of BYETTA and exenatide once weekly.
About Diabetes
Diabetes affects more than 23 million people in
According to the
About BYETTA® (exenatide) injection
BYETTA is the first and only
Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2 diabetes. It is used with metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute for insulin in patients whose diabetes requires insulin treatment. BYETTA is not recommended for use in patients with severe problems digesting food or those who have severe disease of the stomach or kidney.
When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar) is a possible side effect. To reduce this possibility, the dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea is the most common side effect when first starting BYETTA, but decreases over time in most patients.
If patients experience the following severe and persistent
symptoms (alone or in combination): abdominal pain, nausea, vomiting, or
diarrhea, they should talk to their healthcare provider because these
symptoms could be signs of serious medical conditions. BYETTA may reduce
appetite, the amount of food eaten, and body weight. No changes in dose
are needed for these side effects. These are not all of 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 full
prescribing information, visit www.BYETTA.com.
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
P-LLY
(i) "All About Diabetes."
(ii) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
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: 291(3),
(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.
Source:
Amylin
Anne Erickson, 858-754-4443
Cell:
858-349-3195
anne.erickson@amylin.com
or
Lilly
Kindra
Strupp, 317-277-5170
Cell: 317-554-9577
kstrupp@lilly.com
or
Alkermes
Rebecca
Peterson, 617-583-6378
Cell: 617-899-2447
rebecca.peterson@alkermes.com