NCT00693771已完成4 期
A Prospective Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- HbA1c values
研究概览
简要总结
Primary objective:
To show an improvement in HbA1c control after 4 months of treatment with insulin glargine + Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)
Secondary objective:
Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life with basal+ OAD regimen.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Type 2 Diabetes Mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 OADs
- •7.5 ≤ HbA1c ≤ 9.5%
- •FPG ≥6.7 mmol/L
- •History of Diabetes mellitus ≤10 years
- •Premix insulin daily dosage ≤ 50 IU/Day
排除标准
- •Type 1 Diabetes Mellitus
- •Former treated on TZD
- •Pregnancy / Lactation
- •Creatine ≥1.5 mg/dl
- •Hepatic disease, jaundice,or ALT/AST≥ 2.5 times of normal range
- •Hormone therapy,
- •Acute status of Diabetes complications
- •Severe concomitant disease or complications with high risk of unexpected fatal events, like Myocardial Infarct, stroke, heart failure.
- •Allergic to insulin glargine or any ingredient
- •Participation in another clinical trial within 3 months
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
HbA1c values
时间窗: At baseline and 16 weeks
次要结局
- Adverse events including hypoglycemia(From the beginning to the end of the study)
研究者
研究点 (1)
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