NCT00791895已完成4 期
NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) Titrate-To-Target: An Observational Study of the Efficacy of NovoLog® Mix 70/30 in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets on OADs With / Without Once Daily Basal Insulin Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Percentage of subjects achieving HbA1c below 6.5%
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Type 2 diabetes mellitus for at least 12 months
- •HbA1c: 7.5-10.0%
- •An antidiabetic regimen that has been stable for at least 3 months
- •Able and willing to perform SMBG testing as per protocol
排除标准
- •Use of any insulin preparations other than NPH or glargine within the past 6 months
- •Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods)
- •Known or suspected allergy to trial product or agents related to trial product
研究组 & 干预措施
A
Experimental
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Percentage of subjects achieving HbA1c below 6.5%
时间窗: after 16, 32 and 48 weeks, respectively
次要结局
未报告次要终点
研究者
研究点 (1)
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