Comparison Between Low Mixed Insulin and Mid Mixed Insulin AS Starter Insulin For Patients With TYpe 2 Diabetes Mellitus (CLASSIFY Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25 (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with Type 2 diabetes mellitus (T2DM).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) for at least 6 months
- •Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these
- •Have a qualifying hemoglobin A1c (HbA1C) value ≥7.0% and ≤11.0% at screening
- •Have a body mass index (BMI) ≥18.5 and <35.0 kilogram per square meter (kg/m²)
- •Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site
排除标准
- •Have a diagnosis of type 1 diabetes
- •Have had more than 1 episode of severe hypoglycemia within the 6 months before screening
- •Have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)
- •Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range at screening, as determined by the central laboratory
- •Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula <30 milliliter per minute (mL/min), as determined by the central laboratory at screening
- •Have evidence of a significant, active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator
- •Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years
- •Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the participants from following and completing the protocol
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
研究组 & 干预措施
Insulin Lispro Mix25
Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
干预措施: Insulin Lispro Mix25 (Drug)
Insulin Lispro Mix50
Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
干预措施: Insulin Lispro Mix50 (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
时间窗: Baseline, Week 26
HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.
次要结局
- Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26(Baseline, Week 26)
- Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26(Baseline through Week 26)
- Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)(Baseline through Week 26)
- Insulin Dose at Week 26(Week 26)
- Change From Baseline in Fasting Blood Glucose (FBG) at Week 26(Baseline, Week 26)
- Change From Baseline in Body Weight at Week 26(Baseline, Week 26)