NCT00174681已完成4 期
Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes
适应症
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
- 390
- 试验地点
- 6
- 主要终点
- Percentage of subjects achieving HbA1c < 7% at the end of the study.
研究概览
简要总结
Primary objective:
The primary objective of this trial is:
- To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and dietary measures in type 2 diabetics whose blood glucose control is acceptable but not optimal on maximum oral treatment, based on the number of patients achieving a HbA1c value < 7% at the end of treatment.
Secondary objectives:
The secondary objectives of this trial are to compare between the two treatment groups:
- The variation in HbA1c between baseline and end of trial.
- The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia.
- Mean blood glucose levels at different times of the day.
- The variation in weight and lipid in each group between baseline and end of trial.
- The incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patient with any of the following criteria will not be included in the trial:
- •Type 1 diabetics
- •Insulin-treated type 2 diabetics or having previously received long-term insulin, or treated with a thiazolidinedione or glinide
- •Fasting blood glucose < 1.20 g/l.
- •Pregnancy (non-menopausal women must have a pregnancy test before the inclusion visit and effective contraception).
- •Lactation.
- •History of hypersensitivity to the investigational product or to drugs with similar chemical structures.
- •Systemic treatment with corticosteroids irrespective of the dose and irrespective of the previous or anticipated duration of treatment.
- •Treatment with another product under development in the 2 months preceding the date of inclusion in the study.
- •Subject likely to receive treatments prohibited in the protocol during the trial.
- •Cardiovascular, hepatic, neurological, endocrine or any other disease making it difficult to carry out the protocol or interpret the results.
- •Proliferative or rapidly progressive or unstable retinopathy for at least 6 months after treatment by surgery or laser, or requiring surgery or laser in the 3 months following inclusion in the study.
- •Hepatic impairment:ALT and/or AST more than three times the upper limit of normal at the initial assessment.
- •Renal insufficiency:Serum creatinine >177 µmol/l (>20 mg/l) or creatinine clearance <60 ml/min.
- •Previous or current history of alcohol or drug abuse.
- •Mental state rendering the subject incapable of understanding the nature, objectives and possible consequences of the trial.
- •Inability to undertake blood glucose self-monitoring and the injection of insulin alone.
- •Subject unable to accept the restrictions of the protocol (uncooperative, unable to attend the follow-up visits and probably incapable of completing the trial).
- •Subjects deprived of freedom by an administrative or judicial decision.
- •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
Percentage of subjects achieving HbA1c < 7% at the end of the study.
次要结局
未报告次要终点
研究者
研究点 (6)
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