A PROSPECTIVE OBSERVATIONAL STUDY: IMPACT OF SWITCHING TREATMENT TO iGlarLixi ON QOLITY OF LIFE OF TYPE 2 DIABETES PATIENTS PREVIOUSLY ON MULTIPLE DAILY INJECTION INSULIN THERAPY IN JAPAN (SIMPLIFY JAPAN)

SANOFI0 个研究点目标入组 68 人开始时间: 2022年3月17日最近更新: 2024年12月13日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: SANOFI
入组人数: 68
主要终点: Change in the total score of diabetes therapy related-quality of life questionnaire (DTR-QoL)

暂无简介。

•Adult Japanese patients with T2DM who meet all the following inclusion criteria will be eligible for the study:
•Have been treated on MDI therapy, comprising >=2 doses of prandial insulin plus one dose of basal insulin per day, for >=3 months prior to switching and initiating treatment with iGlarLixi under routine clinical practice based on the approved label indication, irrespective of participation in this study.
•Following >=3-month of MDI therapy, Have at least one HbA1c value recorded prior to the baseline PRO assessment.
•Following >=3-month of MDI therapy, Have FPG and weight data available prior to the baseline PRO assessment.
•Baseline HbA1c <8.0%.
•Signed informed consent.

•Patients who meet any of the following criteria will be excluded from the study:
•Patients with confirmed diagnosis of type 1 diabetes mellitus.
•Age <20 years old at enrollment.
•History of receiving GLP-1RA or fixed-ratio combination within 3 months prior to the baseline PRO assessment.
•Total daily insulin dose >30 U/day at baseline.
•Fasting C-peptide <0.6 ng/mL.
•Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m
•Pregnant, breastfeeding or may become pregnant.
•Patients registered in the Following clinical trials.
•Previously participated in any iGlarLixi clinical trial.
•Enrolled in any clinical trial related to diabetes during baseline period and 24-week Follow-up period of this study.
•Off-label use of iGlarLixi.
•Administration other than before breakfast.
•Administration more than once a day.
•A daily dose >20 dose steps.
•Unable to answer and complete the PRO assessment forms by oneself.
•Having conditions/concomitant diseases precluding his/her safe participation in this study.
•eg, active malignant tumor, major systemic disease.
•Having conditions/concomitant diseases that affect evaluation of effectiveness outcomes.
•eg, steroid diabetes, haemoglobinopathy.

Change in the total score of diabetes therapy related-quality of life questionnaire (DTR-QoL)

时间窗: baseline to Week 24

Change in the total score of diabetes therapy related-quality of life questionnaire (DTR-QoL) from baseline to Week 24

Change in Fasting plasma glucose (FPG)(12 weeks and 24 weeks)
Change in fasting serum C-peptide(12 weeks and 24 weeks)
Proportion of Patients reaching HbA1c <7%(12 weeks and 24 weeks)
Proportion of Patients with HbA1c decrease >=0.5%(12 weeks and 24 weeks)
Proportion of Patients with HbA1c decrease >=1%(12 weeks and 24 weeks)
Change in body weight(12 weeks and 24 weeks)
Self-reported adherence to treatment(12 weeks and 24 weeks)
Change in the total score of DTR-QoL(Week 12)
Change in scores for each of the four domains of DTR-QoL(Week 12 and 24)
The total score of diabetes treatment satisfaction questionnaire status version (DTSQs)(baseline)
The total score of diabetes treatment satisfaction questionnaire change version (DTSQc)(Week 24)
Change in glycated hemoglobin A1c (HbA1c)(12 weeks and 24 weeks)
Proportion of Patients reaching Age specific HbA1c targets by Japan diabetes Society guideline(12 weeks and 24 weeks)
Incidence and severity of hypoglycemia(12 weeks and 24 weeks)
Incidence and severity of GI disorders(12 weeks and 24 weeks)
Change in Total daily insulin dose and basal insulin dose(12 weeks and 24 weeks)

发起方