临床试验/NCT00655200

NCT00655200已完成不适用

Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

Novo Nordisk A/S0 个研究点目标入组 2,286 人开始时间: 2008年2月最近更新: 2023年11月22日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 2,286
主要终点: Safety profile of Insulin Detemir among Filipino patients

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2 Diabetes Mellitus.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 0 Years 至 6 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
•Newly diagnosed insulin naive patients
•Patients currently on human insulin or on basal insulin
•Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
•Usage should be in accordance with the current prescribing information (See attached prescribing information)

排除标准

•Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
•Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
•Pregnant women, those planning to become pregnant, or women who are breastfeeding
•Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
•Children below 6 years old

研究组 & 干预措施

A

干预措施: insulin detemir (Drug)

结局指标

主要结局

Safety profile of Insulin Detemir among Filipino patients

时间窗: 3 months follow-up visit

次要结局

未报告次要终点

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

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