Phase 3 Once Weekly Investigational Diabetes Therapy Also Improved Glucose Control in Patients Switching from Exenatide Taken Twice a Day
SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY), and Alkermes, Inc.(Nasdaq: ALKS) today announced results from a 52-week open-label clinicalstudy that showed the durable efficacy of exenatide once weekly, a long-actingrelease formulation of exenatide. Patients taking exenatide once weekly overthe course of one year sustained a similar improvement in glucose control[A1C: -2.0%+/-0.08; fasting plasma glucose (FPG) -47+/-3 mg/dL] compared tothose receiving treatment for 30 weeks [A1C change from baseline: -1.9%+/-0.08(LS mean+/-SE)]. This study also showed that patients who switched fromBYETTA(R) (exenatide) injection after 30 weeks to exenatide once weeklyexperienced additional improvements in A1C and fasting plasma glucose.Seventy-four percent of all patients in the study achieved an endpoint A1C of7 percent or less at 52 weeks. Patients in both treatment groups experienced astatistically significant and sustained average weight loss of 9.5 pounds over52 weeks. These findings were presented at the 68th Annual Scientific Sessionsof the American Diabetes Association (ADA) in San Francisco.
BYETTA is indicated as adjunctive therapy to improve glycemic control inpatients with type 2 diabetes mellitus who are taking metformin, asulfonylurea, a thiazolidinedione, a combination of metformin and asulfonylurea, or a combination of metformin and a thiazolidinedione, but havenot achieved adequate glycemic control.
'Diabetes is a lifelong condition that requires constant management ofblood glucose or blood sugar as well as weight. In DURATION-1 trial, patientssignificantly reduced their blood glucose levels and, on average, lost a totalof over nine pounds. These improvements were sustained for a year,' said JohnB. Buse, M.D., Ph.D., Professor of Medicine, Director of the Diabetes CareCenter, and Chief of the Division of Endocrinology at the University of NorthCarolina School of Medicine in Chapel Hill. 'Importantly, the study resultsalso showed that steady-state levels of exenatide may result in improvementsin a variety of glucose parameters. If approved, exenatide once weekly mayprovide patients with a treatment option that is on board 24 hours a day,seven days a week, helping to manage their blood sugar and, secondarily, theirweight.'
Study Design and Findings
The Diabetes Therapy Utilization: Researching Changes in A1C, Weight andOther Factors Through Intervention with Exenatide ONce Weekly (DURATION-1)study was a 30-week, randomized, open-label study of 295 patients with type 2diabetes (baseline values: A1C 8.3%+/-1.0, FPG 169+/-43 mg/dL,weight 225+/-44lbs., BMI 35+/-5.0 kg/m2, diabetes duration 6.7+/-5.0 years;mean+/-SD) who were treated with exenatide once weekly 2.0 mg or BYETTA twicedaily as outlined in the approved label subcutaneously. Following the first 30weeks of treatment, 258 patients entered an open-label treatment withexenatide once weekly. Patients either remained on exenatide once weekly orswitched from BYETTA to exenatide once weekly for an additional 22 weeks.
Following the 30-week comparison period, patients (evaluable populationN=241) who continued on exenatide once weekly showed sustained improvements inA1C and fasting plasma glucose levels at week 52 [A1C: -2.0%+/-0.1;FPG -47+/-3 mg/dL (LS mean+/-SE)]. Patients who switched from BYETTA toexenatide once weekly had further improvements in glycemic control [A1C: -2.0%+/-0.1; FPG - 43+/-3 mg/dL] that were consistent with those of patientsreceiving exenatide once weekly for 52 weeks. These data suggested theadditional impact of continuous exenatide levels on glycemic control.
In both groups, A1C reduction was similar at 52 weeks. Seventy-two percentof patients treated with exenatide once weekly achieved an endpoint A1C of 7percent or less, and 54 percent achieved an A1C of 6.5 percent or less. Inpatients who switched from BYETTA to exenatide once weekly, 75 percent ofpatients achieved an endpoint A1C of 7 percent or less and 53 percent achievedan A1C of 6.5 percent or less. An A1C of below 7 percent is the target forgood glucose control as recommended by the ADA. Unlike the weight gain that iscommonly associated with insulin therapy and many oral diabetes medications,exenatide once weekly was associated with an average weight loss of 9.5 poundsover 52 weeks.
Exenatide once weekly uses a proprietary technology for long-actingmedications developed by Alkermes.
