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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)

SIMPLIFY JAPAN (SIMPLIFY JAPAN)

66

The study was conducted between March 2022 and July 2023. In total, 70 individuals were screened; 4 were excluded due to meeting exclusion or not meeting inclusion criteria, meaning 66 people with T2D were enrolled from 15 clinical sites, all of whom were included in the safety analysis set. Forty two (68.9%) participants were male, and 19 (31.1%) were female. The mean (SD) age was 62.1 (13.3) years; the mean (SD) duration of diabetes was 11.8 (12.2) years; the mean body mass index (SD) was 25.7 (3.9) kg/m2; and the mean HbA1c (SD) was 6.73 (0.66) %. The proportion of participants who had HbA1c <7.0% was 62.3%. The majority of the participants had mild to moderate renal impairment at baseline.

The study recruited Japanese people with T2D who were aged over 20 years and had switched to iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, (at the discretion of their physician) after receiving MDI therapy (at least two daily doses of prandial insulin plus one dose of BI per day) for over 3 months, had at least one HbA1c value, as well as fasting plasma glucose (FPG) and body weight data, from before study entry, and had a baseline HbA1c of under 8.0%. All consecutive eligible people were invited to participate until the enrolment goal was met. People were excluded if they had type 1 diabetes; received a GLP-1 RA or fixed-ratio combination within 3 months before the baseline PRO assessment: received a total daily insulin dose of over 30 U/ day at baseline; had fasting C-peptide levels of under 0.6 ng/ml; had estimated glomerular filtration rate (eGFR) of under 30 ml/min/1.73 m2; or were pregnant, breastfeeding or could become pregnant during the study. The initial once daily dose of iGlarLixi was determined according to the insulin component of the individuals previous medication by the attending physician.

During the baseline period, 27 hypoglycemic episodes were reported in 11/66 participants(16.7%) in the safety analysis set, corresponding to an incidence rate of 1.7 events per person-year. At weeks 12 and 24, ten participants(15.2%) had 21 hypoglycemic episodes and 12 participants (18.2%) had 30 hypoglycemic episodes, respectively. The incidence rate of hypoglycemic episodes at weeks 12 and 24 was 1.1 and 1.0 events per person-year, respectively. Overall, no severe hypoglycemic episodes were reported. At week 24, six participants (9.1%) had seven documented symptomatic hypoglycemic episodes, five participants (7.6%) had 20 asymptomatic hypoglycemic episodes, and three participants (4.5%) had three episodes of probable symptomatic hypoglycemia. No hospitalizations or emergency room visits were required for hypoglycemia. In total, 18 participants (27.3%) had 26 gastrointestinal AEs during iGlarLixi therapy. At week 24, the incidence rate of gastrointestinal AEs was 0.8 events per person-year. The most common gastrointestinal AEs were decreased appetite, nausea and diarrhea. All gastrointestinal AEs were mild or moderate in severity.

Sixty-six participants were enrolled and 61 were included in the full analysis set. Significant improvements were observed in total DTR-QOL score from baseline to week 24 (mean change + 10.8 points; P < 0.001), with higher scores observed in individual domains related to social/daily activities, treatment satisfaction, and reductions in treatment-related anxiety (P < 0.05). A small HbA1c increase was noted at week 24 (P < 0.001), while this did not appear to adversely affect HRQOL or treatment satisfaction. A significant reduction in body weight was observed at week 12 (mean change - 0.7 kg; P = 0.046). Self-reported treatment adherence increased from baseline to week 24, with the proportion of participants who never missed an insulin injection increasing from 55.7 to 77.6%. At week 24, the incidence of hypoglycemia and gastrointestinal adverse events was 18.2 and 27.3%, respectively.

Switching from MDI to iGlarLixi therapy in Japanese people with T2D was associated with enhanced HRQOL (despite slight elevation in HbA1c) and improved treatment adherence, with a favorable safety profile. These findings support the beneficial role of iGlarLixi in the management of T2D in real-world Japanese clinical practice.

May. 19, 2024

Aug. 27, 2024

https://doi.org/10.1007/s13300-024-01645-z

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1041210151

Yabe Daisuke

Gifu University Hospital

1-1 Yanagido, Gifu City, Gifu, 501-1194, JAPAN

ydaisuke@gifu-u.ac.jp

Inoue Tadakazu

IQVIA Services Japan G.K.

1 Keikyu Dai-1 Building ,4-10-18 Takanawa,Minato-ku,Tokyo,Japan

+81-80-3753-2361

SIMPLIFY_office@iqvia.com

Complete

Mar. 22, 2022

Observational

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/1.73m2.
- 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.

Both

Type 2 Diabetes

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

- 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

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Jan. 25, 2022

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