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.
Participant must be at least 18 of age inclusive, at the time of signing the informed consent.
Type 2 diabetes mellitus diagnosis.
Participants who are treated for at least 3 months prior to the screening visit with an adequate dose of 1-3 OADs.
HbA1c 7.5-11%
Diagnosed with T1DM
BMI <20 kg/m2 or BMI ≥40 kg/m2
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.
Contraindications to iGlarLixi according to the China NMPA approved label.
Shanghai Zhongshan Hospital
Lead sponsor
Sanofi (China) Investment Co., Ltd
Collaborator