The 12-Month Efficacy and Safety of Insulin Detemir and NPH Insulin in Basal-Bolus Therapy for the Treatment of Type 1 Diabetes
| العنوان: | The 12-Month Efficacy and Safety of Insulin Detemir and NPH Insulin in Basal-Bolus Therapy for the Treatment of Type 1 Diabetes |
|---|---|
| المؤلفون: | Eberhard Standl, Hanne Lang, Anthony Roberts |
| المصدر: | Diabetes Technology & Therapeutics. 6:579-588 |
| بيانات النشر: | Mary Ann Liebert Inc, 2004. |
| سنة النشر: | 2004 |
| مصطلحات موضوعية: | Adult, Blood Glucose, medicine.medical_specialty, endocrine system diseases, Injections, Subcutaneous, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Insulin, Isophane, NPH insulin, Drug Administration Schedule, law.invention, Eating, Endocrinology, Insulin Detemir, Randomized controlled trial, law, Internal medicine, Diabetes mellitus, Humans, Hypoglycemic Agents, Insulin, Medicine, Aged, Insulin detemir, Glycemic, Glycated Hemoglobin, Type 1 diabetes, business.industry, Fasting, Middle Aged, medicine.disease, Hypoglycemia, Insulin, Long-Acting, Clinical trial, Medical Laboratory Technology, Diabetes Mellitus, Type 1, business, medicine.drug |
| الوصف: | This trial compared the long-term safety and efficacy of the basal insulin preparations, insulin detemir and NPH insulin, in basal-bolus therapy for patients with type 1 diabetes.This multinational open, parallel-group trial randomized patients to receive insulin detemir or NPH insulin twice daily in addition to mealtime human soluble insulin. Doses were titrated towards predefined glycemic targets. After an initial 6-month treatment period, patients were invited to participate in a 6-month extension period. A total of 289 from 421 elected to continue in the trial, of which 252 completed.Glycemic control as assessed by hemoglobin A1c (insulin detemir, 7.88%; NPH insulin, 7.78%; difference not significant) and fasting plasma glucose (insulin detemir, 10.1 mmol/L; NPH insulin, 9.84 mmol/L; difference not significant) was similar in both treatment groups at end point, with hemoglobin A1c little changed from baseline and fasting plasma glucose slightly decreased. There was some evidence for a risk reduction for hypoglycemia in association with insulin detemir, although this was not statistically significant (relative risk overall hypoglycemia, 0.71, P = 0.139; relative risk nocturnal hypoglycemia, 0.71, P = 0.067), and hypoglycemic events were fewer in each of the 12 months. There was a significant treatment difference with regard to weight outcome; NPH insulin was associated with weight gain (1.4 kg), but there was no mean weight gain (-0.3 kg) in the insulin detemir cohort (baseline-adjusted between-group difference at 12 months, 1.66 kg, P = 0.002). There were no obvious between-group differences in other safety parameters.Glycemic control is maintained with insulin detemir during long-term treatment. At equivalent glycemic control to NPH insulin, insulin detemir is associated with a lack of weight gain and a trend towards a reduced risk of nocturnal hypoglycemia when used in basal-bolus therapy with mealtime soluble human insulin. |
| تدمد: | 1557-8593 1520-9156 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2b79d9c9d6cd068c5956d8d974f9ae0eTest https://doi.org/10.1089/dia.2004.6.579Test |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi.dedup.....2b79d9c9d6cd068c5956d8d974f9ae0e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15578593 15209156 |
|---|