Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 882
- 试验地点
- 1
- 主要终点
- Incidence of serious adverse drug reactions including major hypoglycaemic events
研究概览
简要总结
This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time. The study will also look at the blood glucose control, frequency of dose adjustment, clinic visits, and time spent training patients to self-titrate.
The objective of diabetes management is to achieve blood glucose levels as close as possible to normal in order to avoid late stage diabetic complications. Self-titration (where patients adjust insulin dosage themselves) offers the potential for better blood glucose control than titration only at clinic visits. In recent years treatment of type 2 diabetes in the United Kingdom has moved from hospitals to GP surgeries or local clinics. Patients with type 2 diabetes, in general, have not been trained in self-titration to the same degree as patients with type 1 diabetes. Less experience in self-titration could impact the level of blood glucose control and outcome for these patients.
Data from this study will be pooled with data from NN304-3714 (NCT00825643) and will be reported in the final study report for NN304-3714.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After the participating physician/nurse's decision has been made to initiate once daily Levemir® therapy (within the license of the product), any patient with type 2 diabetes of 18 years or older who is currently treated with diet, exercise and one or more OADs can be offered to participate
排除标准
- •Patients unable to give written informed consent
- •Current treatment with insulin
- •Patient deemed unable or unwilling to self-titrate
- •Known or suspected allergy to study product or related products
- •Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
研究组 & 干预措施
A
干预措施: insulin detemir (Drug)
结局指标
主要结局
Incidence of serious adverse drug reactions including major hypoglycaemic events
时间窗: during treatment
次要结局
- Frequency of insulin adjustment(at approximately 12 and 20 weeks)
- Proportion of patients achieving FBG below 6.0 mmol/l +/- hypo(defined by the average of the last three FBGs)
- Body weight(at approximately 12 and 20 weeks)
- Total number of visits/contacts to the clinic, related to titration(at approximately 12 and 20 weeks)
- HCP time used on titration training(at baseline and approximately 12 and 20 weeks)
- Proportion of patients who achieved equal or greater than 1% HbA1c reduction after initiation of insulin detemir without experiencing hypoglycaemic episodes(at approximately 12 and 20 weeks)
- Incidence of serious adverse events and all adverse events(during treatment)
- Incidence of hypoglycaemic events(in the 4 weeks preceding the baseline, 12 and 20 week visits)
- HbA1c(at the interim study visit at 12 weeks and the end of the study visit at 20 weeks)
- Variability and mean of the patient's self-monitored plasma glucose measurements(at approximately 12 and 20 weeks)