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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 12 - Item Well-Being Questionnaaire (WBQ12)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
1
insulin glargine
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
12 - Item Well-Being Questionnaaire (WBQ12)
时间窗: before the switch to insulin glargine and at 3 and 9 months of follow up.
Glycaemic controll will be asessed by HbA1c values
时间窗: week 12 and week 40
The fear of hypoglycaemia scale (HFS)
时间窗: before the switch to insulin glargine and at 3 and 9 months of follow up.
次要结局
- Incidence of symptomatic hypoglycemia and severe hypoglycemia(sreening to follow-up phases)