Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents-a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,316
- 试验地点
- 24
- 主要终点
- hemoglobin A1c (HbA1c) change
研究概览
简要总结
This study is a prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT). It will compare the efficacy and safety of iGlarLixi versus standard of care in adult T2DM patients with poor glycemic control, who are using 1 to 3 OADs in a real-world clinical practice setting. A total of 1,316 subjects from approximately 40 research centers in China will be randomly assigned in a 1:1 ratio to one of the following treatment groups: Group 1: iGlarLixi for blood glucose control; and Group 2: Standard of care for diabetes (basal insulin or premixed insulin, excluding any GLP-1RA-containing drugs). Considering the substantial difference in intervention methods between the two groups, the study is designed as non-blinded with an open-label approach.
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
- •Participant must be at least 18 of age inclusive, at the time of signing the informed consent.
- •Type 2 diabetes mellitus diagnosis.
- •Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs.
- •HbA1c 7.5-11%
- •Further intensification with an additional antidiabetic injectable medication is indicated to achieve glycaemic target at the discretion of the study physician according to approval labelling.
- •Participants who have signed informed consent form (ICF).
排除标准
- •Diagnosed with T1DM
- •BMI <20 kg/m2 or BMI ≥40 kg/m2
- •Treatment with more than 3 oral antidiabetic medications, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of insulin is allowed, as is prior insulin treatment for gestational diabetes.
- •Contraindications to iGlarLixi according to the China NMPA approved label.
- •Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study.
- •Participants who involved in other clinical trial within 3 months prior to the time of screening visit.
- •Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- •Pregnant or breast-feeding woman.
- •Woman of childbearing potential not protected by highly effective contraceptive method of birth control and/or who is unwilling or unable to be tested for pregnancy.
- •Conditions/situations such as:
- •Participant with short life expectancy. Participant with conditions/concomitant diseases making him/her not evaluable for the primary efficacy endpoint (eg, hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to screening).
- •Participant with conditions/concomitant diseases precluding his/her safe participation in this study (eg, active malignant tumor, major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period).
- •Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures.
研究组 & 干预措施
iGlarLixi group
The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice.
干预措施: iGlarLixi (insulin glargine/lixisenatide) (Drug)
Standard of care (SOC) group.
The control drug treatment is standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs). Participants will receive standard of care with the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice.
干预措施: standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs) (Drug)
结局指标
主要结局
hemoglobin A1c (HbA1c) change
时间窗: from baseline to week 24
The primary endpoint is the change in HbA1c from baseline to week 24 (percentage \[%\]).
次要结局
- Percentage of participants requiring rescue therapy during the 24-week treatment period(24 weeks)
- Time to first study drug discontinuation during 24 weeks (day)(24 weeks)
- Time to first treatment intensification (add-on) or change (switch) after randomization during 24 weeks (day)(24 weeks)
- Study drug medication adherence of the study, as measured by medication possession ratio (MPR) (%)(24 weeks)
- Change from baseline to Week 24 in diabetes medication treatment satisfaction scores (total score and by sub scales), using the treatment related impact measure diabetes (TRIM-D) questionnaire.(24 weeks)
- All cause healthcare resource utilization (HCRU) from baseline to EOT（end of treatment(24 weeks)
- Incidence and event rate of hypoglycemia(24 weeks)
- Incidence and event rate of Adverse events (AE)(24 weeks)
- Incidence and event rate of serious adverse events (SAE)(24 weeks)
- Incidence and event rate of adverse events of special interest (AESI)(24 weeks)
- Incidence and event rate of AEs leading to treatment discontinuation, vital signs, and safety laboratory test values.(24 weeks)
- Proportion of subjects achieving HbA1c < 7%, with no weight gain and no hypoglycemia (defined as ADA grades 1, 2, or 3) at week 24(24 weeks)
- Change in weight from baseline to week 24(24 weeks)
- Change in Fasting plasma glucose from baseline to Week 24.(24 weeks)
- Change in 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 24 (each time point and average daily value).(24 weeks)
- Proportion of participants reaching HbA1c target <7% with no hypoglycemia (defined as ADA level 1, 2 or 3) at Week 24.(24 weeks)
- Proportion of subjects achieving HbA1c < 7% at week 24(24 weeks)
- Proportion of participants reaching HbA1c target <7% with no clinically relevant hypoglycemia (defined as ADA level 2 or 3) at Week 24(24 weeks)
- Change in CGM metrics(TIR / TAR / TBR /mean daily glucose / TITR / CV / GMI / SD of mean glucose) from baseline to Week 24(24 weeks)
- Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24(24 weeks)
- Change in waist from baseline to Week 24(24 weeks)
- Total insulin dose in each group at Week 24(24 weeks)
- Change in fasting C-peptide from baseline to Week 24(24 weeks)