Diabetes
Conditions
Interventions
Experimental Group:The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as in
Control Group: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
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 (Met, SGLT2i, alpha-GI, glinide or SU). 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. 6.Participants who have signed informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Diagnosed as T1DM. 2.BMI =40 kg/m^2. 3. Have received treatment with more than three oral hypoglycemic drugs or any injectable drugs within 30 days prior to the date of the conformity assessment. Temporary/emergency use of insulin and previous insulin treatment for gestational diabetes are permitted. 4. The contraindications of iGlarLixi mentioned in the instructions approved by China's NMPA. 5. Any clinically significant abnormalities found during physical examination, laboratory tests or vital signs at the time of screening, or any major systemic disease that the researcher believes would limit the patient's full participation in the study during the study period. 6. Screen the subjects who have participated in other clinical trials within the three months prior to the visit. 7. Subjects with severe renal impairment whose estimated glomerular filtration rate (eGFR) was less than 30 mL/min/1.73 m^2. 8. Pregnant or lactating women. 9. Fertile women who have not taken effective contraceptive measures and/or women who are unwilling or unable to undergo pregnancy tests. 10. Other special conditions/circumstances, such as: The subjects had a short life expectancy. The subjects' conditions or concomitant diseases prevented them from being evaluated for the primary efficacy endpoint (for example, hemoglobinopathy or hemolytic anemia, having received blood or plasma products within 3 months prior to screening). The subjects have conditions or concomitant diseases that prevent them from safely participating in this study (e.g., active malignant tumors, major systemic diseases, presence of clinically significant diabetic retinopathy, or macular edema that may require laser treatment during the study period). Any situation where the subjects do not cooperate or may not comply with the research procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in HbA1c from baseline to week 24 (percentage [%]);Other glycemic control parameters and waist;Total insulin dose, percentage of participants requiring rescue therapy and therapy compliance;Health related quality of life (HRQoL) and treatment satisfaction;All cause healthcare resource utilization (HCRU) from baseline to EOT(end of treatment); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants at HbA1c target, proportion of participants at HbA1c target without weight gain and/no hypo; | — |
Countries
China
Contacts
Public ContactXiaoying Li
Zhongshan Hospital, Fudan University
Outcome results
None listed