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| Name | Class |
|---|---|
| Sanofi (China) Investment Co., Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iGlarLixi group | Experimental | 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. |
|
| Standard of care (SOC) group. | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iGlarLixi (insulin glargine/lixisenatide) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| hemoglobin A1c (HbA1c) change | The primary endpoint is the change in HbA1c from baseline to week 24 (percentage [%]). | from baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving HbA1c < 7% at week 24 | 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 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CRP from baseline to week 24. | Change in CRP from baseline to week 24. | from baseline to week 24 |
Inclusion Criteria:
Participants who have signed informed consent form (ICF).
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoying li, Professor | Contact | +862164041990 | li.xiaoying@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC / Anhui Provincial Hospital | Recruiting | Hefei | Anhui | 230001 | China |
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|
| standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs) | Drug | 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. |
|
| Change in weight from baseline to week 24 | 24 weeks |
| Change in Fasting plasma glucose from baseline to Week 24. | 24 weeks |
| Change in 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 24 (each time point and average daily value). | 24 weeks |
| Proportion of participants reaching HbA1c target <7% with no hypoglycemia (defined as ADA level 1, 2 or 3) at Week 24. | 24 weeks |
| Proportion of participants reaching HbA1c target <7% with no clinically relevant hypoglycemia (defined as ADA level 2 or 3) at Week 24 | 24 weeks |
| Change in CGM metrics(TIR / TAR / TBR /mean daily glucose / TITR / CV / GMI / SD of mean glucose) from baseline to Week 24 | 24 weeks |
| Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24 | 24 weeks |
| Change in waist from baseline to Week 24 | 24 weeks |
| Total insulin dose in each group at Week 24 | 24 weeks |
| Change in fasting C-peptide from baseline to Week 24 | 24 weeks |
| Percentage of participants requiring rescue therapy during the 24-week treatment period | 24 weeks |
| Time to first study drug discontinuation during 24 weeks (day) | 24 weeks |
| Time to first treatment intensification (add-on) or change (switch) after randomization during 24 weeks (day) | 24 weeks |
| Study drug medication adherence of the study, as measured by medication possession ratio (MPR) (%) | 24 weeks |
| Change from baseline to Week 24 in diabetes medication treatment satisfaction scores (total score and by sub scales), using the treatment related impact measure diabetes (TRIM-D) questionnaire. | TRIM scores range from 0 to 100 with a higher score indicating a better health state. | 24 weeks |
| All cause healthcare resource utilization (HCRU) from baseline to EOT(end of treatment | 24 weeks |
| Incidence and event rate of hypoglycemia | any hypoglycemia, ADA grades 1-2-3 | 24 weeks |
| Incidence and event rate of Adverse events (AE) | 24 weeks |
| Incidence and event rate of serious adverse events (SAE) | An SAE is defined as any adverse event occurring at any dose that meets one or more of the following criteria:
| 24 weeks |
| Incidence and event rate of adverse events of special interest (AESI) | The following events are designated as AESIs:
| 24 weeks |
| Incidence and event rate of AEs leading to treatment discontinuation, vital signs, and safety laboratory test values. | 24 weeks |
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230022 | China |
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| The First People's Hospital of Huizhou | Recruiting | Huizhou | Guangdong | 516003 | China |
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| Shenzhen Third People's Hospital | Recruiting | Shenzhen | Guangdong | 518112 | China |
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| Heilongjiang Provincial Hospital | Recruiting | Harbin | Heilongjiang | 150036 | China |
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| Xinxiang Central Hospital | Recruiting | Xinxiang | Henan | 453003 | China |
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| Wuhan Fourth Hospital / Wuhan Puai Hospital | Recruiting | Wuhan | Hubei | 430030 | China |
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| Hunan Provincial People's Hospital / The First Affiliated Hospital of Hunan Normal University | Recruiting | Changsha | Hunan | 410005 | China |
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| Hengyang Central Hospital | Recruiting | Hengyang | Hunan | 421001 | China |
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| Affiliated Nanhua Hospital, University of South China | Recruiting | Hengyang | Hunan | 421002 | China |
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| The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210003 | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| The First Clinical Hospital of Jilin Academy of Chinese Medicine Sciences | Recruiting | Changchun | Jilin | 130021 | China |
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| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanghai Tenth People's Hospital / Tenth People's Hospital of Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
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| Shanghai East Hospital, Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| Shanghai Pudong New Area Punan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200125 | China |
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| Shanghai Tongren Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200336 | China |
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| Minhang Hospital, Fudan University / Central Hospital of Minhang District, Shanghai | Recruiting | Shanghai | Shanghai Municipality | 201199 | China |
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| Shanghai Qingpu District Central Hospital / Qingpu Branch of Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201700 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
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| Jiaxing First Hospital | Recruiting | Jiaxing | Zhejiang | 314001 | China |
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| Ningbo No. 2 Hospital | Recruiting | Ningbo | Zhejiang | 315010 | China |
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| Ningbo Medical Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | 315040 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C479460 | lixisenatide |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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