Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine (QoL)
A Multicenter Clinical Trial to Evaluate Quality of Life in Patients With Type 2 Diabetes Before and After Changing Therapy to a Combination of Insulin Glargine and Oral Antidiabetic Drugs in a Real Life Situation
Primary objective:
To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are switched to insulin glargine.
Secondary objective:
To determine:
change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine, change in weight, change in insulin dose.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Bromma、瑞典
- Sanofi-Aventis Administrative Office
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
lists of inclusion and exclusion criteria:
Inclusion Criteria:
- Patients with type 2diabetes inadequately controlled on a combination of OAD + NPH insulin for more than three months
- Stable OAD therapy for at least three months, according to the following specified daily dose: glibenclamide> 3, 5 mg, glipizid >5 mg, glimeperid >2mg, metformin>1000 mg, acarbose >150 mg
- HbA1c > 7,0%
- Ability to perform QoL assessment
- Body Mass Indes: women <30 and men <32
Exlusion criteria:
- Autoimmune diabetes, as defined by WHO
- Ongoing treatment with tiasolidindion drug
- Retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry
- Drug abuse
- Hypersensitivity to insulin glagine excipients
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
insulin glargine
|
Lantus (insulin glargine [rDNA origin] injection), individual dosing , subcutaneous injection, 100 IU/ml. Duration of treatment will be judge by the investigator. Last QoL assessed in the study will be 9 months after start of glargine treatment. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The fear of hypoglycaemia scale (HFS)
大体时间：before the switch to insulin glargine and at 3 and 9 months of follow up.
|
before the switch to insulin glargine and at 3 and 9 months of follow up.
|
|
12 - Item Well-Being Questionnaaire (WBQ12)
大体时间：before the switch to insulin glargine and at 3 and 9 months of follow up.
|
before the switch to insulin glargine and at 3 and 9 months of follow up.
|
|
Glycaemic controll will be asessed by HbA1c values
大体时间：week 12 and week 40
|
week 12 and week 40
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Incidence of symptomatic hypoglycemia and severe hypoglycemia
大体时间：sreening to follow-up phases
|
sreening to follow-up phases
|
合作者和调查者
赞助
调查人员
- 研究主任：Margareta Olsson-Birgersson、sanofi-aventis, Sweden
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
2型糖尿病的临床试验
-
Jin-Hee AhnAsan Medical Center未知HER-2基因扩增 | HER-2 蛋白过表达
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.未知
-
AIM Vaccine Co., Ltd.Zhejiang Provincial Center for Disease Control and Prevention尚未招聘
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological Pharmaceutical Co...尚未招聘
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College主动，不招人
-
AIM Vaccine Co., Ltd.Hunan Provincial Center for Disease Control and Prevention完全的
-
Peking UniversityCenters for Disease Control and Prevention, China; Beijing Pinggu District Hospital; Peking University...完全的
Insulin Glargine的临床试验
-
Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbH完全的
-
Mannkind Corporation完全的
-
Julphar Gulf Pharmaceutical IndustriesProfil Institut für Stoffwechselforschung GmbH完全的