NCT00970528已完成4 期
A Randomized, Parallel Group, Open-Label, Active-Controlled Study Comparing Acarbose With Voglibose in Patients Who Are Inadequately Controlled With Insulin Glargine Alone or in Combination With Metformin Based on Glycemic Control
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
- Bayer
- 入组人数
- 124
- 主要终点
- Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetic patients whose blood glucose levels were inadequately controlled with insulin glargine alone or in combination with 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-79 years
- •Type 2 diabetes inadequately controlled with insulin glargine alone or in combination with metformin
- •Diagnosed of type 2 diabetes for at least 6 months prior to screening
- •Treated with tolerable, stable dose of insulin glargine and/or metformin for at least 3 months prior to screening
- •HbA1C > 7.0 and </= 10.0% at screening
排除标准
- •Type 1 diabetes patients
- •Myocardial infarction, unstable angina or coronary artery bypass surgery within previous 6 months
- •Clinical evidence of active liver disease, or serum ALT or AST 3 times the upper limit of the normal (ULN) range
- •Serum creatinine >/= 1.5 mg/dl for males, >/= 1.4 mg/dl for females
- •Active proliferative diabetic retinopathy
- •Any other anti-diabetic medications except insulin glargine and metformin within 4 weeks prior to study entry
- •Gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesis, malabsorption syndrome, chronic diarrhea states, enteropathies, inflammatory bowel disease, partial intestinal obstruction, and large hernias)
- •Galactose intolerance
- •Pregnancy
- •Delivery, abortion, or lactation within less than three cycles before the start of treatment
- •No use of contraceptive in childbearing aged. Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration.
- •Hypersensitivity to the active substances or any of gradient of the study drug ingredients
- •Treatment with any medication including corticosteroid or herb medication that can affect blood glucose level in the 3 months prior to study entry
- •Any disease or condition that in the opinion of the investigator may interfere with completion of the study
研究组 & 干预措施
Arm 1
Experimental
干预措施: Acarbose (Glucobay, BAYG5421) (Drug)
Arm 2
Active Comparator
干预措施: Voglibose (Basen) (Drug)
结局指标
主要结局
Glycosylated hemoglobin (HbA1c)
时间窗: Change from baseline to week 24, at week -2, 0, 8 and 24
次要结局
- Fasting blood glucose concentration(At week -2, 0, 4, 8, 16 and 24)
- Blood concentration of triglyceride(At week -2 and 24)
- Self monitoring blood glucose concentration(6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24))
- Blood concentration of low density lipoprotein(At week -2 and 24)
- Blood concentration of total cholesterol(At week -2 and 24)
- Blood concentration of apolipoprotein B(At week -2 and 24)
- Body weight, Body Mass Index(BMI)(At week -2, 0, 4, 8, 16 and 24)
- Blood concentration of high density lipoprotein(At week -2 and 24)
- High Sensitivity C-reactive protein (hs-CRP)(At week -2 and 24)
- Blood concentration of apolipoprotein A-1(At week -2 and 24)
- Blood concentration of Glucagon-like peptide-1 (GLP-1)(At week -0 and 24)
研究者
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