NCT00653302已完成4 期
Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment
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
- 280
- 试验地点
- 1
- 主要终点
- % of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
研究概览
简要总结
Primary objective:
- Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
Secondary objectives:
- Determination of the predictive criterion of HbA1c final,
- Determination of the predictive criterion of weight variation,
- Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),
- Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).
Safety:
- Adverse Event (AE)/Serious Adverse Event (SAE) assessments
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
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known type 2 diabetes for at least 2 years
- •No history of Ketoacidosis
- •BMI> 25 & <35 kg/m2
- •Type 2 diabetes treated with oral bi or tritherapy for at least 6 months
- •With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),
- •and metformin at minimal posology 1700mg/day (1320 mg of metformin),
- •HbA1c >= 7.5 and <11% for 2 different dosages during the last year
排除标准
- •Type 1 diabetes
- •Glucophage intolerability
- •Pregnancy
- •Breast feeding
- •Partial pancreatectomy
- •Hypersensitivity to insulin glargine excipient
- •Renal failure with creatinin>135 µmol/L for male and >110 µmol/L for female patient
- •Hepatitis with transaminases >3ULN
- •Pre-proliferative or proliferative retinopathy
- •Acute cardiovascular accident within the last 6 months
- •Previous treatment with insulin within the last 6 months before randomization
研究组 & 干预措施
1
Experimental
Lantus once a day plus Glucophage 1000mg, twice a day per os
干预措施: Lantus (insulin glargine) + Glucophage (Metformin) (Drug)
结局指标
主要结局
% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).
时间窗: During the study conduct
次要结局
- AE/SAE evaluation(from the informed consent signed up to the end of the study)
- HbA1c and weight variations (final value - basal value)(during the study)
- Determination of the predictive criterion of HbA1c final(During the study conduct)
- Determination of the predictive criterion of weight variation(During all the study conduct)
研究者
研究点 (1)
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