The Medical Technology Blog

Drug Delivery Insight – Research & Development

Amylin Pharmaceuticals, Eli Lilly and Alkermes have revealed new analyses from the DURATION-3 and -4 trials showing patients treated with the investigational medication Bydureon (exenatide extended-release for injectable suspension) experienced significant improvements in select cardiovascular (CV) risk factors, in comparison with patients who received commonly prescribed diabetes treatments. The analyses showed that patients receiving Bydureon for the treatment of Type II diabetes experienced improvements in composite endpoints related to body weight, abnormal blood pressure and abnormal lipid levels.

The initial DURATION-3 trial was an open-label study of 467 patients not achieving adequate glucose control using metformin therapy alone or in combination with a sulphonylurea. Subjects were randomised to receive treatment with Bydureon or titrated doses of Lantus (insulin glargine, Sanofi). The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, safety endpoints including hypoglycaemia, CV risk biomarkers and patient-reported outcomes.

Interim results from DURATION-3′s ongoing extension found that patients receiving Bydureon and completing 84 weeks of therapy showed statistically significant reduction in body weight (vs Lantus; treatment difference: 9.8 lbs). There was also, statistically significantly more patients in the Bydureon treatment arm met a composite endpoint of A1C <7 per cent plus target systolic blood pressure (<130 mmHg) and LDL cholesterol (<100 mg/dL) (15.7 per cent vs 7.9 per cent with Lantus); and met a composite endpoint of A1C<=6.5 per cent plus target systolic blood pressure (<130 mmHg) and LDL cholesterol (<100 mg/dL) (11.2 per cent vs 5.1 per cent with Lantus).

The 26-week, double-blind, randomised, four-arm parallel DURATION-4 study enrolled 820 drug-naive patients with Type II diabetes and compared Bydureon with metformin, Januvia (sitagliptin, Merck & Co) and Actos (pioglitazone HCI, Takeda) monotherapies. The primary endpoint was reduction in A1C levels, while secondary endpoints included change in body weight along with other parameters of glucose control, CV health and patient-reported outcomes. The post hoc analyses showed patients treated with Bydureon or metformin were more likely to achieve clinically relevant composite goals than patients treated with Actos or Januvia. Researchers evaluated how many patients in each treatment group achieved a composite endpoint of A1C<7 per cent, no weight gain and no minor or major hypoglycaemia (48 per cent for Bydureon vs 22 per cent for Actos, 35 per cent for Januvia and 46 per cent for metformin); and reached a composite endpoint of A1C<7 per cent plus target systolic blood pressure (<130 mmHg) and target LDL cholesterol (<100 mg/dL) (16 per cent for Bydureon vs 10 per cent for Actos, 7 per cent for Januvia and 13 per cent for metformin).

In the DURATION-3 study, gastro-intestinal adverse events were among those most commonly reported; however, the number of new cases of all adverse events declined during the extension phase of the trial. In the DURATION-4 study, the most frequently reported adverse events among Bydureon users were nausea and diarrhoea. These data are consistent with the previously reported profiles of Bydureon and Byetta (exenatide) injection.




Espicom Business Intelligence

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