NCT00552370已完成4 期
A Randomized, Open-Label, Parallel-Design Trial. Glycemia Optimization Treatment: Safety of Glucose Control Using Dosing Algorithms With Lantus®(Insulin Glargine [rDNA Origin[) in Adult Individuals 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
- 5,062
- 主要终点
- To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of-study target for self monitored blood glucose (SMBG).
研究概览
简要总结
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of -study target for self monitored plasma glucose(SMPG), in patients with Type 2 diabetes mellitus, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must give their signed informed consent.
- •Diagnosis of Type 2 DM for at least 6 months.
- •Males and females greater than or equal to 18 years of age.
- •A1c greater than or equal to 7.0%.
- •Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only.
- •Demonstrated willingness and ability to inject insulin glargine.
- •Able to understand and willing to comply with procedures required by the protocol and have access to a phone.
- •Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG) and use of the algorithm calculator (AL-CAL).
- •BMI greater than 25.0 kg/m
- •Subjects who, in the opinion of the investigator, should be initiated on insulin therapy.
排除标准
- •Cardiac status New York Heart Association (NYHA) III-IV (Appendix A).
- •For subjects treated with metformin (Glucophager, Glucophage XRr, Glucovancer, Metaglipr , or Avandametr) plus a serum creatinine greater than 1.5 mg/dL (133 μmol/L) for males or greater than 1.4 mg/dL (124 μmoL) for females, the inability or unwillingness to discontinue these medications, and to remain off them through the entire study.
- •For subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study.
- •Planned pregnancy, pregnancy, or lactation.
- •Serum creatinine greater than 3.0 mg/dL (266 μmol/L).
- •Serum glutamic pyruvic transaminase (SGPT) greater than 2.5 x the upper limit of normal range.
- •Any current malignancy or cancer within the past 5 years (except adequately treated basal cell carcinoma or cervical carcinoma in situ).
- •Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Hypersensitivity to Lantus® insulin or any of its components.
- •Any disease or condition, including the abuse of illicit drugs, prescription medicines, or alcohol that, in opinion of the sponsor/investigator, may interfere with the completion of the study.
- •Current (last 2 months) insulin therapy.
- •With the exception of thiazolidinediones (for all potential subjects) and for subjects who are taking metformin and have an exclusionary creatinine level, the ability or unwillingness to continue pre-study anti-hyperglycemia agents at pre-study dosages through the entire study.
- •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
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of-study target for self monitored blood glucose (SMBG).
时间窗: From the start to the end of the study
次要结局
- To compare the number of subjects whose final A1c is <7.0% at the end of the study for the 5 dosing algorithms.(From the start to the end of the study)
研究者
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