Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea
| العنوان: | Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea |
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| المؤلفون: | Richard, Bergenstal, Andrew, Lewin, Timothy, Bailey, Denise, Chang, Titus, Gylvin, Victor, Roberts, S, Yates |
| المصدر: | Current Medical Research and Opinion. 25:65-75 |
| بيانات النشر: | Informa Healthcare, 2008. |
| سنة النشر: | 2008 |
| مصطلحات موضوعية: | Adult, Blood Glucose, Male, medicine.medical_specialty, medicine.drug_class, Insulin, Isophane, Biphasic Insulins, Type 2 diabetes, Insulin aspart, Internal medicine, Diabetes mellitus, medicine, Humans, Hypoglycemic Agents, Insulin, Insulin Aspart, Glycemic, Venoms, business.industry, General Medicine, Middle Aged, medicine.disease, Sulfonylurea, Metformin, Sulfonylurea Compounds, Endocrinology, Diabetes Mellitus, Type 2, Exenatide, Female, Peptides, business, medicine.drug |
| الوصف: | To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial.Subjects (N = 372, T2DM6 months, ageor = 18 andor = 80 years, HbA1cor = 8%, insulin naive not achieving glycaemic targets, receiving metformin and sulfonylurea) were randomized 1: 1: 1 to receive either BIAsp 30 QD (12 U before supper); BIAsp 30 BID (12 U divided equally between pre-breakfast and pre-supper); or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter). Efficacy (HbA1c, fasting plasma glucose [FPG]) and safety (adverse events and hypoglycemic episodes) were assessed.Glycemic control achieved with both BIAsp 30 BID and BIAsp 30 QD was superior to that with exenatide (BIAsp 30 BID-exenatide: HbA1c difference -0.91% [95% CI: -1.23 to -0.59%] and BIAsp 30 QD-exenatide: difference: -0.67% [95% CI: -0.99 to -0.34%]). At the end of the study, more subjects achieved HbA1c7% andor = 6.5% in the BIAsp 30 BID group than in the exenatide group (HbA1c7%: 37% vs. 20%, p = 0.0060; HbA1cor = 6.5%: 25% vs. 8%, p = 0.0004, respectively). Combined hypoglycemic episodes (major, minor, symptoms only) were reported by 56%, 61%, and 29% of the subjects in the BIAsp 30 QD, BIAsp 30 BID, and exenatide groups, respectively. Weight gain was observed in the BIAsp 30 group (BIAsp 30 QD: 2.85 kg, BIAsp 30 BID: 4.08 kg) and weight loss was observed in the exenatide group (-1.96 kg). Nausea or vomiting was responsible for discontinuation of seven subjects in the exenatide group and one subject in the BIAsp 30 BID group.Significantly more T2DM patients (poorly controlled with combination metformin/sulfonylurea) achieved glycemic goals when treated with BIAsp 30 than with exenatide. The high baseline HbA1c values (approximately 10.2%) and the long duration of diabetes (approximately 9 years) suggests that some subjects may have been in an advanced stage of their diabetes and may not have had sufficient beta-cell function for a GLP-1 mimetic to be effective. The insulin-treated groups had more minor hypoglycemic events and weight gain but less gastrointestinal side-effects. In summary, BIAsp 30 was more efficacious in helping patients with high baseline HbA1c achieve glycemic goals.www.clinicaltrials.gov, NCT00097877. |
| تدمد: | 1473-4877 0300-7995 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e7e5e893d20d94b9dfd7d494ff44e7c9Test https://doi.org/10.1185/03007990802597951Test |
| رقم الانضمام: | edsair.doi.dedup.....e7e5e893d20d94b9dfd7d494ff44e7c9 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14734877 03007995 |
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