The PREDICTIVETM Study: a multinational, prospective observational study to evaluate the safety and efficacy of insulin detemir treatment in patients with type 1 and 2 diabetes—data from the Japan cohort
| Autor: | Hirotaka Watada, Kazuyuki Tobe, Yujin Shuto, Kohei Kaku, Narihito Yoshioka, Takashi Kadowaki, Mitsuyoshi Namba, Yasuo Terauchi, Kohjiro Ueki, Yuichiro Yamada, Eiichi Araki |
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| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
Type 1 diabetes business.industry Endocrinology Diabetes and Metabolism Incidence (epidemiology) Type 2 diabetes medicine.disease Surgery Diabetes mellitus Internal medicine Cohort Internal Medicine medicine Clinical endpoint business Glycemic Insulin detemir medicine.drug |
| Zdroj: | Diabetology International. 3:11-20 |
| ISSN: | 2190-1686 2190-1678 |
| DOI: | 10.1007/s13340-011-0051-x |
| Popis: | The PREDICTIVETM Study of Japan was an open-label, non-randomized 52-week observational study to evaluate the safety and efficacy of insulin detemir when used in routine clinical practice. Patients with either type 1 or 2 diabetes in whom insulin detemir was to be prescribed but without a previous history of using insulin detemir were eligible to participate. The primary endpoint was an incidence of serious adverse drug reaction (SADR) for the entire observational period. Data were collected at baseline, 12, 26, and 52 weeks. A total of 3,519 patients were enrolled in 540 institutions between 2008 and 2009. Thirty patients (0.9%) reported 32 SADRs. The rate of total hypoglycemic episodes was 1.51 episodes/patient-year in patients with type 1 diabetes and 0.23 episodes/patient-year in patients with type 2 diabetes. The rate of total hypoglycemic episodes did not increase during the observational period. Significant reductions were observed at 52 weeks in HbA1c levels (0.51% in type 1 diabetes, P |
| Databáze: | OpenAIRE |
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