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This study aims to confirm that SHR20004 is more effective than placebo in controlling blood glucose in patients with type 2 diabetes. Evaluate the efficacy, safety, and pharmacokinetics of SHR20004 after 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noiiglutide Injection | Experimental |
| |
| Noiiglutide Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noiiglutide Injection | Drug | Experimental group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycated hemoglobin (HbA1c) relative to baseline at week 24 in SHR20004 compared to placebo. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieve the HbA1c target value (<7.0%) | Week 26 | |
| The proportion of subjects who achieve the HbA1c target value (≤ 6.5%) | Week 26 | |
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Inclusion Criteria
Exclusion Criteria
The researchers suspect that the subjects may be allergic to the investigational drug;
Discontinuation of GLP-1 RA treatment due to safety/tolerability reasons or lack of effectiveness reasons in the past (excluding cases where GLP-1 RA is discontinued due to non efficacy or non safety reasons such as economic reasons, and no GLP-1 RA has been used within the past 3 months before screening);
Before screening, any of the following drugs or treatments were used:
History or evidence of any of the following diseases before screening:
During screening, laboratory tests showed the following situations:
Abnormal 12 lead electrocardiograms with clinical significance during screening, such as grade II or III atrioventricular block (excluding right bundle branch block), long QT syndrome or QTc>500 ms, severe arrhythmia, etc. (mild T wave and ST segment changes may not be ruled out if the researcher judges that the subject's clinical symptoms are not obvious) in the absence of a pacemaker;
Within the first 4 weeks of screening, the amount of blood donated or lost is ≥ 400 mL, or a blood transfusion has been received;
Pregnant or lactating women, as well as fertile men or women who are unwilling to use contraception during the study period;
The researchers believe that the subjects have any other factors that may affect the efficacy or safety evaluation of this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital Affiliated to Capital | Beijing | Beijing Municipality | 100020 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Noiiglutide Placebo |
| Drug |
Placebo Comparator group |
|
| Changes in fasting plasma glucose relative to baseline |
| Week 26 |
| Changes in fasting body weight relative to baseline | Week 26 |
| Changes in plasma glucose levels relative to baseline 2 hours after meals | Week 26 |
| 7-point self-test of blood glucose (SMBG) spectrum relative to baseline changes | Week 26 |
| Changes in blood pressure relative to baseline | Week 26 |
| Changes in fasting insulin relative to baseline | Week 26 |
| Changes in C-peptide relative to baseline | Week 26 |
| Changes in insulin levels relative to baseline 2 hours after meals | Week 26 |
| Changes in C-peptide levels relative to baseline 2 hours after meals | Week 26 |
| Adverse events (AE) | Week 26 |
| ADA of SHR20004 | Week 26 |
| Nab of SHR20004 | Week 26 |
| The concentration of SHR20004 in plasma at steady state | Week 26 |
| D004700 | Endocrine System Diseases |