Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents

Official title

Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents-a Pragmatic Randomized Controlled Trial

Overview

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.

Interventions

• Drug iGlarLixi (insulin glargine/lixisenatide)
  The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice.
• Drug standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs)
  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 the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice.

Primary outcome measures

• hemoglobin A1c (HbA1c) change [Time frame: from baseline to week 24]

Secondary outcome measures (12)

• Proportion of subjects achieving HbA1c < 7% at week 24 [Time frame: 24 weeks]
• Proportion of subjects achieving HbA1c < 7%, with no weight gain and no hypoglycemia (defined as ADA grades 1, 2, or 3) at week 24 [Time frame: 24 weeks]
• Change in weight from baseline to week 24 [Time frame: 24 weeks]
• Change in Fasting plasma glucose from baseline to Week 24. [Time frame: 24 weeks]
• Change in 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 24 (each time point and average daily value). [Time frame: 24 weeks]
• Proportion of participants reaching HbA1c target <7% with no hypoglycemia (defined as ADA level 1, 2 or 3) at Week 24. [Time frame: 24 weeks]
• Proportion of participants reaching HbA1c target <7% with no clinically relevant hypoglycemia (defined as ADA level 2 or 3) at Week 24 [Time frame: 24 weeks]
• Change in CGM metrics(TIR / TAR / TBR /mean daily glucose / TITR / CV / GMI / SD of mean glucose) from baseline to Week 24 [Time frame: 24 weeks]
• Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24 [Time frame: 24 weeks]
• Change in waist from baseline to Week 24 [Time frame: 24 weeks]
• Total insulin dose in each group at Week 24 [Time frame: 24 weeks]
• Change in fasting C-peptide from baseline to Week 24 [Time frame: 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 24 centers

• The First Affiliated Hospital of USTC / Anhui Provincial Hospital — Hefei
• The First Affiliated Hospital of Anhui Medical University — Hefei
• The First People's Hospital of Huizhou — Huizhou
• Shenzhen Third People's Hospital — Shenzhen
• Heilongjiang Provincial Hospital — Harbin
• Xinxiang Central Hospital — Xinxiang
• Wuhan Fourth Hospital / Wuhan Puai Hospital — Wuhan
• Hunan Provincial People's Hospital / The First Affiliated Hospital of Hunan Normal Univers — Changsha
• … and 16 more centers

Identifiers

NCT: NCT07307235 · 20250424044409703

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗