Lantus for Diabetic Patients Treated in Clalit Outpatient Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,229
- 试验地点
- 1
- 主要终点
- Decrease in HbA1c level
研究概览
简要总结
Treatment of diabetes mellitus type II with basal insulin, for patients treated in Clalit outpatient clinics that are not adequately controlled with current treatment.
详细描述
Patients with diabetes treated in outpatient clinics will be recruited by their primary care physician. Recruitment period will be 3 months per center and each patient will be followed for 7 months Diabetes specialists will be responsible for 50-65 primary care physicians. The specialists will advise and direct the primary care physician through the whole study period.
The study protocol includes patients treated with different types of non short- acting insulin. Insulin Lantus (including dose) will be started by the primary physician, if needed after consulting the Diabetes Specialist. The treatment should follow the study protocol.
Patients will have 3 pre-scheduled visits in their clinic: 1. At the beginning of study. 2. After 3 months. 3. At study end (after 6 month). An additional telephone contact will take place 1 month after last visit. to evaluate adherence to therapy Data collecting: Data including HbA1c, FPG,current diabetic treatment, dose of insulin Lantus, and relevant additional diseases\complaints will be collected at each visit. Additional information as demographic data, medical history will be collected at beginning of study.
Safety: Hypoglycaemic episodes will be recorded
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II Diabetic patients
- •HbA1c >8.0% (result from preceding 4 months)
- •Written informed consent
- •Life expectancy of at least 1 year.
- •Patients' agree to discontinue current long acting insulin (if applicable).
- •Patients who according to their GP are eligible to the study.
排除标准
- •Type I diabetes
- •Pregnancy and\or lactation.
- •Allergy to basal insulin
- •Patients suffering from a disease that requires repeated hospitalizations E.g.: severe CHF, sever renal failure, active malignancy.
- •Patients who are not able to give consent.
- •Patients face difficulties in mobility and/or verbal communication with the treating physician.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Decrease in HbA1c level
时间窗: 6 months
次要结局
- Safety measures(7 months)