NCT03018938已完成4 期
Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC 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
- 入组人数
- 814
- 试验地点
- 32
- 主要终点
- Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
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
- •have type 2 diabetes as defined by World Health Organization (WHO) criteria
- •are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
- •most recent HbA1c value ≥7.5% within 12 weeks of study entry
- •in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
- •willing to start with insulin treatment
排除标准
- •have a diagnosis of type 1 diabetes
- •have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
- •have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
- •are pregnant or breastfeeding, or intend to become pregnant during the course of the study
- •are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
研究组 & 干预措施
Insulin Analog Mid Mixture
Experimental
Insulin analog mid mixture given subcutaneously (SC).
干预措施: Insulin Analog Mid Mixture (Drug)
Basal Insulin Analog
Experimental
Basal insulin analog given SC.
干预措施: Basal Insulin Analog (Drug)
结局指标
主要结局
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
时间窗: Baseline, 24 Weeks
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.
次要结局
- Change From Baseline to Week 48 in HbA1c(Baseline, 48 Weeks)
- Change From Baseline to Week 24 in Venous Fasting Plasma Glucose(Baseline, 24 Weeks)
- Percentage of Participants Who Achieve HbA1c <7% at Week 48(48 Weeks)
- Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose(Baseline, 48 Weeks)
- Percentage of Participants Who Achieve HbA1c <7% at Week 24(24 Weeks)
- Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose(Baseline, 24 Weeks)
- Rate of Hypoglycemia at Week 24 and 48(24 Weeks, 48 Weeks)
- Change From Baseline to Week 48 in Venous Fasting Plasma Glucose(Baseline, 48 Weeks)
- Total Daily Insulin Dose at Week 24 and 48(24 Weeks, 48 Weeks)
- Number of Participants With Insulin Treatment Change at Week 48(Baseline through 48 Weeks)
- Change From Baseline to Week 24 in Body Weight(Baseline, 24 Weeks)
- Change From Baseline to Week 48 in Body Weight(Baseline, 48 Weeks)
- Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24(24 Weeks)
- Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48(48 Weeks)
- Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score(Baseline, 48 Weeks)
研究者
研究点 (32)
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