NCT00562172已完成4 期
Lantus vs Sulfonylurea as add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile.
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
- 75
- 试验地点
- 1
- 主要终点
- ß-cell Function parameter
研究概览
简要总结
Primary objective:
To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients
Secondary objective:
To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus patients on metformin monotherapy
- •7% ≤ HbA1c ≤ 12%
- •20 kg/m² ≤BMI ≤ 35 kg/m²
- •Diabetes duration: at least 6 months
排除标准
- •Type 1 Diabetes Mellitus patients
- •Clinical evidence of active liver disease, or serum Alanine AminoTransferase 3 times the upper limit of the normal range
- •Serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
- •Acute and chronic metabolic acidosis, including diabetic ketoacidosis
- •History of alcohol or other substance abuse
- •Pregnancy or not using contraceptive in childbearing aged women
- •Known hypersensitivity to Lantus, SU or metformin
- •Any disease or condition that in the opinion of the investigator may interfere with completion of the study
- •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: Metformin (Drug)
2
Active Comparator
干预措施: Glimepiride (Drug)
1
Experimental
干预措施: Insulin glargine (Drug)
2
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
ß-cell Function parameter
时间窗: From the signature of the Informed Consent Form (ICF) up to the end of study
Glucose Homeostasis and glycemic control status
时间窗: From the signature of the Informed Consent Form (ICF) up to the end of study
次要结局
- Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine(End of the study)
研究者
研究点 (1)
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