Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents
Recruiting · NCT07307235 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Zhongshan Hospital
View the official record on ClinicalTrials.gov →Interventions studied
iGlarLixi (insulin glargine/lixisenatide)standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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%
- 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
- 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.
- 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.
- Participants who involved in other clinical trial within 3 months prior to the time of screening visit.
- Participant who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
- Pregnant or breast-feeding woman.
- 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.
- 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 is running
24 locations listed.
- The First Affiliated Hospital of USTC / Anhui Provincial Hospital - Hefei, Anhui, China
- The First Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- The First People's Hospital of Huizhou - Huizhou, Guangdong, China
- Shenzhen Third People's Hospital - Shenzhen, Guangdong, China
- Heilongjiang Provincial Hospital - Harbin, Heilongjiang, China
- Xinxiang Central Hospital - Xinxiang, Henan, China
- Wuhan Fourth Hospital / Wuhan Puai Hospital - Wuhan, Hubei, China
- Hunan Provincial People's Hospital / The First Affiliated Hospital of Hunan Normal University - Changsha, Hunan, China
- Hengyang Central Hospital - Hengyang, Hunan, China
- Affiliated Nanhua Hospital, University of South China - Hengyang, Hunan, China
- The Second Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China
- The Second Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, China
- The First Clinical Hospital of Jilin Academy of Chinese Medicine Sciences - Changchun, Jilin, China
- Zhongshan Hospital, Fudan University - Shanghai, Shanghai Municipality, China
- Shanghai Tenth People's Hospital / Tenth People's Hospital of Tongji University - Shanghai, Shanghai Municipality, China
- Shanghai East Hospital, Tongji University - Shanghai, Shanghai Municipality, China
- Shanghai Pudong New Area Punan Hospital - Shanghai, Shanghai Municipality, China
- Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine - Shanghai, Shanghai Municipality, China
- Minhang Hospital, Fudan University / Central Hospital of Minhang District, Shanghai - Shanghai, Shanghai Municipality, China
- Shanghai Qingpu District Central Hospital / Qingpu Branch of Zhongshan Hospital, Fudan University - Shanghai, Shanghai Municipality, China
- Zhejiang Provincial People's Hospital - Hangzhou, Zhejiang, China
- Jiaxing First Hospital - Jiaxing, Zhejiang, China
- Ningbo No. 2 Hospital - Ningbo, Zhejiang, China
- Ningbo Medical Center Lihuili Hospital - Ningbo, Zhejiang, China