NCT00358124已完成4 期
Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
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
- 220
- 试验地点
- 1
- 主要终点
- The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
研究概览
简要总结
To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus for at least one year;
- •Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
- •Glycated hemoglobin between 7.5 and 11 % units, inclusive;
- •Willingness to accept, and ability to inject insulin glargine therapy
排除标准
- •Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
- •Congestive heart failure requiring pharmacological treatment;
- •Serum creatinine > 1.5 mg/dl for males, or > 1.4 mg/dl for females;
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
- •Planned radiological examinations requiring administration of contrasting agents;
- •Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
- •History of hypoglycemia unawareness;
- •Pregnancy or lactation;
- •Failure to use adequate contraception (women of current reproductive potential only);
- •Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
- •BMI >25 kg/m2;
- •Malignancy except basal cell carcinoma within the last five years;
- •History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse;
- •Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study;
- •Incapability to comply with study procedures
结局指标
主要结局
The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
Other efficacy variables were the change from baseline in FPG, serum lipids and weight.
次要结局
- Secondary efficacy parameters were: a mean change from baseline in FPG
- Mean change from baseline in fasting insulin/C-peptide levels
- Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)
- Mean change from baseline for bodyweight.
- Health-related quality of life was compared between the baseline visit and the follow-up assessments
研究者
研究点 (1)
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