iGlarLixi vs standard diabetes care in adults with Type 2 diabetes in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a real-world, open-label, multicenter randomized trial in about 1,316 adults with Type 2 diabetes across roughly 40 Chinese centers. Participants are assigned 1:1 to receive either iGlarLixi or standard of care (basal or premixed insulin without GLP-1 receptor agonists). The trial design is pragmatic and non-blinded, reflecting everyday clinical practice while comparing outcomes in routine settings. Eligibility includes adults with HbA1c 7.5–11% who have been on 1–3 oral agents for at least 3 months and require further injectable therapy as judged by investigators. The study aims to assess real-world effectiveness and safety of the two approaches in a population with poor glycemic control.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of USTC / Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• The First People's Hospital of Huizhou
  Huizhou, Guangdong, China Recruiting
• Shenzhen Third People's Hospital
  Shenzhen, Guangdong, China Recruiting
• Heilongjiang Provincial Hospital
  Harbin, Heilongjiang, China Recruiting
• Xinxiang Central Hospital
  Xinxiang, Henan, China Recruiting

Study contacts

• Study coordinator: Xiaoying li, Professor
• Email: li.xiaoying@zs-hospital.sh.cn
• Phone: +862164041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.