NCT00360698已完成4 期
Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study.
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
- 106
- 试验地点
- 2
- 主要终点
- Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
研究概览
简要总结
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus, Type 2
- •25 < BMI < 45 kg/m²
- •7,5% < HbA1c < 9%
- •Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months
排除标准
- •Type 1 diabetes mellitus
- •Treatment with OADs only
- •Treatment with thiazolidinediones, with exenatide or with pramlintide
- •Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
- •Active proliferative diabetic retinopathy,
- •Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
- •Breast-feeding
- •History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
- •Treatment with systemic corticosteroids in the 3 months prior to study entry
- •Treatment with any investigational product in the 2 months prior to study entry
- •Previous treatment with insulin glulisine
- •Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
- •Impaired hepatic function
- •Impaired renal function
- •History of drug or alcohol abuse
- •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
insulin glulisine+insulin glargine+metformin+glimepiride
Other
Bolus arm
干预措施: Insulin Glargine (Drug)
insulin glulisine+insulin glargine+metformin+glimepiride
Other
Bolus arm
干预措施: Glimepiride (Drug)
insulin glulisine+insulin glargine+metformin+glimepiride
Other
Bolus arm
干预措施: Insulin Glulisine (Drug)
insulin glulisine+insulin glargine+metformin+glimepiride
Other
Bolus arm
干预措施: Metformin (Drug)
insulin glargine+metformin+glimepiride
Other
Control arm
干预措施: Insulin Glargine (Drug)
insulin glargine+metformin+glimepiride
Other
Control arm
干预措施: Glimepiride (Drug)
insulin glargine+metformin+glimepiride
Other
Control arm
干预措施: Metformin (Drug)
结局指标
主要结局
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
时间窗: at the end of treatment (week 24)
Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c \<7%
次要结局
- Glycosylated Haemoglobin (HbA1c) Value(at the end of treatment (week 24))
- Change in Glycosylated Haemoglobin (HbA1c) Value(from baseline to the end of treatment (week 24))
- Daily Mean Plasma Glucose(at the end of treatment (week 24))
- Change in Daily Mean Plasma Glucose(from baseline to the end of treatment (week 24))
- Change in Weight(from baseline to the end of treatment (week 24))
- Daily Dose of Insulin Glargine(at the end of treatment (week 24))
- Daily Dose of Insulin Glulisine(at the end of treatment (week 24))
- Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL(during treatment period (12 weeks))
- Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL(during treatment period (12 weeks))
- Rate of Severe Symptomatic Hypoglycemia(during treatment period (12 weeks))
研究者
研究点 (2)
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