Type 2 Diabetes
Conditions
Keywords
diabetes, iGlarLixi, RCT
Brief summary
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.
Interventions
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.
DRUGstandard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)
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.
Sponsors
Shanghai Zhongshan Hospital
Sanofi (China) Investment Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant must be at least 18 of age inclusive, at the time of signing the informed consent. 2. Type 2 diabetes mellitus diagnosis. 3. Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs. 4. HbA1c 7.5-11% 5. 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).
Exclusion criteria
1. Diagnosed with T1DM 2. BMI \<20 kg/m2 or BMI ≥40 kg/m2 3. 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. 4. Contraindications to iGlarLixi according to the China NMPA approved label. 5. 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. 6. Participants who involved in other clinical trial within 3 months prior to the time of screening visit. 7. Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 8. Pregnant or breast-feeding woman. 9. 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. 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hemoglobin A1c (HbA1c) change | from baseline to week 24 | The primary endpoint is the change in HbA1c from baseline to week 24 (percentage \[%\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving HbA1c < 7% at week 24 | 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 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 | — |
| 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 | TRIM scores range from 0 to 100 with a higher score indicating a better health state. |
| All cause healthcare resource utilization (HCRU) from baseline to EOT（end of treatment | 24 weeks | — |
| Incidence and event rate of hypoglycemia | 24 weeks | any hypoglycemia, ADA grades 1-2-3 |
| Incidence and event rate of Adverse events (AE) | 24 weeks | — |
| Incidence and event rate of serious adverse events (SAE) | 24 weeks | An SAE is defined as any adverse event occurring at any dose that meets one or more of the following criteria: 1. Results in death 2. Is life-threatening 3. Requires hospitalization or prolongs existing hospitalization 4. Results in persistent or significant disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other important medical events |
| Incidence and event rate of adverse events of special interest (AESI) | 24 weeks | The following events are designated as AESIs: 1. Pregnancy in female subjects or pregnancy in female partners of male subjects exposed to IMP/NIMP 2. Symptomatic overdose of IMP/NIMP (serious or non-serious) 3. Alanine aminotransferase (ALT) elevation \>3×ULN |
| Incidence and event rate of AEs leading to treatment discontinuation, vital signs, and safety laboratory test values. | 24 weeks | — |
Countries
China
Contacts
CONTACTXiaoying li, Professor
Outcome results
None listed