Efficacy and Safety of Insulin Degludec in a Flexible Dosing Regimen vs Insulin Glargine in Patients With Type 1 Diabetes (BEGIN: Flex T1): A 26-Week Randomized, Treat-to-Target Trial With a 26-Week Extension
| Autor: | Stephen C. Bain, John G. Cooper, Priscilla Hollander, Edward Franek, S. C Tamer, David Russell-Jones, B. Miranda-Palma, Chantal Mathieu, Jens Larsen |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Insulin degludec
Adult Blood Glucose Male medicine.medical_specialty Endocrinology Diabetes and Metabolism medicine.medical_treatment Clinical Biochemistry Insulin Glargine Self Administration Biochemistry Drug Administration Schedule law.invention Endocrinology Randomized controlled trial law Internal medicine Diabetes mellitus medicine Humans Hypoglycemic Agents Dosing Glycated Hemoglobin Type 1 diabetes Dose-Response Relationship Drug Insulin glargine business.industry Endocrine Care Insulin Biochemistry (medical) Middle Aged medicine.disease Insulin Long-Acting Regimen Diabetes Mellitus Type 1 Treatment Outcome Female business medicine.drug |
| Zdroj: | The Journal of Clinical Endocrinology and Metabolism |
| ISSN: | 1945-7197 0021-972X |
| Popis: | Objective: This study investigated the efficacy and safety of insulin degludec (IDeg) once daily (OD), varying injection timing day to day in subjects with type 1 diabetes. Research Design and Methods: This 26-week, open-label, treat-to-target, noninferiority trial compared IDeg forced flexible (Forced-Flex) OD (given in a fixed schedule with a minimum 8 and maximum 40 hours between doses) with IDeg or insulin glargine (IGlar) given at the same time daily OD. In the 26-week extension, all IDeg subjects were transferred to a free-flexible (Free-Flex) regimen, which allowed any-time-of-day dosing, and compared with subjects continued on IGlar. Results: After 26 treatment weeks, mean glycosylated hemoglobin was reduced with IDeg Forced- Flex (−0.40%), IDeg (−0.41%), and IGlar (−0.58%). IDeg Forced-Flex noninferiority was achieved. Fasting plasma glucose reductions were similar with IDeg Forced-Flex and IGlar but greater with IDeg (−2.54 mmol/L) than IDeg Forced-Flex (−1.28 mmol/L) (P = .021). At week 52, IDeg Free-Flex subjects had similar glycosylated hemoglobin but greater fasting plasma glucose reductions than IGlar subjects (−1.07 mmol/L) (P = .005). Confirmed hypoglycemia rates (plasma glucose |
| Databáze: | OpenAIRE |
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