iGlarLixi vs Standard Care for Uncontrolled Type 2 Diabetes in Adults on Oral Agents
This study aims to compare the effectiveness of iGlarLixi versus standard care in managing uncontrolled type 2 diabetes in adults who are currently on oral medications.
iGlarLixi (insulin glargine/lixisenatide)
+ standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: December 15, 2025
Actual date on which the first participant was enrolled.This study focuses on comparing the effectiveness and safety of a diabetes medication called iGlarLixi against the usual care in adult patients with type 2 diabetes who have poor blood sugar control, despite using 1 to 3 oral diabetes medications. The study is important as it aims to improve care for this population in a real-world setting, potentially addressing the challenge of uncontrolled diabetes. The research involves 1,316 participants from approximately 40 centers in China, who will be randomly assigned to one of two treatment groups. In the first group, participants will receive iGlarLixi for blood sugar control. The second group will receive the standard care for diabetes, which could be basal insulin or premixed insulin, but will not include any GLP-1RA-containing drugs. As the intervention methods differ significantly between the two groups, the study is designed to be open-label, meaning both the participants and researchers know which treatment is being used. The study's results will be evaluated based on the effectiveness and safety of each treatment approach.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1316 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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. 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active Comparator