A Prospective, Multicentre, Non-controlled, Observational, 52-weeks Study: the Evaluation of the Body Weight Progress During the Treatment With Insulin Detemir in Type 1 or 2 Diabetes Patients, Previously Treated With Other Basal Insulins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 580
- 主要终点
- Change in body weight and BMI
研究概览
简要总结
This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients. A local extension will be conducted in Slovenia in order to reach the planned 400 patients for the sub-analysis of Slovenian patients.
Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus (Type 1 or type 2)
- •BMI greater than 27 kg/m^2, or more than 3 kg weight increase since start of insulin therapy
排除标准
- •Subjects currently being treated with insulin detemir
- •Subjects who were previously enrolled in this study;
- •Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
- •Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Change in body weight and BMI
时间窗: during 12 months of treatment
次要结局
- Change in body weight at different BMI subgroups(at insulin start, 12 and 6 months before treatment and after 3, 6, 9 and 12 months of treatment)
- Change in number of hypoglycaemic events during 4 weeks proceeding routine visits(after 6 and 12 months of treatment)
- Number of adverse drug reactions (ADR)(after 6 and 12 months of treatment)
- Change in HbA1C(from insulin start and 12 and 6 months before treatment and after 6 and 12 months of treatment)
- Change in waist perimeter(from insulin start and after 6 and 12 months of treatment)
- Change in FPG (Fasting Plasma Glucose)(from 12 and 6 months before treatment after 6 and 12 months of treatment)
- Change in blood pressure(from insulin start and 6 and 12 months after treatment)