SIMPLIFY JAPAN

JRCT ID: jRCT1041210151

Registered date:19/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 17/03/2022
• Target sample size: 68
• Study type: Observational

Outcome(s)

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

Secondary Outcome

- Change in the total score of DTR-QoL from baseline to Week 12.
- Change in scores for each of the four domains of DTR-QoL from baseline to Week 12 and 24.
- The total score of diabetes treatment satisfaction questionnaire status version (DTSQs) at baseline and the score will be stratified by the number of prandial insulin injections per day at baseline.
-The total score of diabetes treatment satisfaction questionnaire change version (DTSQc) at Week 24 and the score will be stratified by the number of prandial insulin injections per day at baseline.

Following endpoints will be evaluated over 12 weeks and 24 weeks.
- Change in glycated hemoglobin A1c (HbA1c) from baseline
- Change in Fasting plasma glucose (FPG) from baseline
- Change in fasting serum C-peptide from baseline
- Proportion of Patients reaching HbA1c <7%
- Proportion of Patients reaching Age specific HbA1c targets by Japan diabetes Society guideline
- Proportion of Patients with HbA1c decrease >=0.5%
- Proportion of Patients with HbA1c decrease >=1%
- Change in body weight from baseline
- Self-reported adherence to treatment
- Incidence and severity of hypoglycemia
- Incidence and severity of GI disorders
- Change in Total daily insulin dose and basal insulin dose

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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/1.73m2.
- 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.

Related Information

• Primary Sponsor: Yabe Daisuke