Type 2 Diabetes
Conditions
Interventions
None listed
Sponsors
Yabe Daisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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 30 U/day at baseline. - Fasting C-peptide 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of diabetes therapy related-quality of life questionnaire (DTR-QoL) from baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 =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 | — |
Contacts
Public ContactTadakazu Inoue
IQVIA Services Japan G.K.
Outcome results
None listed