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This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR101 Injection | Experimental | Participants will receive once daily GZR101 Injection with or without pre-dinner meal-time insulin, s.c, treat-to-target dose |
|
| GZR33-70 Injection | Experimental | Participants will receive once daily GZR33-70 Injection with or without pre-dinner meal-time insulin, s.c., treat-to-target dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR101 Injection | Drug | Once daily |
| |
| GZR33 Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment | Week 0, week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment | Week 0, Week 16 |
| Change in 7-point SMPG profile | Change from baseline in 7-point SMPG profile after 16 weeks of treatment: the mean and the CV |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baozhuo Wang | Contact | 01056456746 | baozhuo.wang@ganlee.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency | Gan & Lee Pharmaceuticals. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 01 | Recruiting | Tianjin | 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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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Once daily |
|
| Insulin aspart | Drug | Once daily |
|
| Week 0, Week 16 |
| Incidence and Rate of Treatment-emergent AE/SAEs | A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period. | Week 0, Week 19 |
| Incidence and Rate of hypoglycemia Events | Hypoglycaemia alert episodes (level 1) are defined as episodes that are sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (>=) 3.0 and less than (<) 3.9 mmol/L (>= 54 and < 70 mg/dL) confirmed by BG meter. Clinically significant hypoglycaemic episodes (level 2) are defined as episodes that are sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) are defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) are defined as episodes that are associated with severe cognitive impairment requiring external assistance for recovery. | Week 0, Week 19 |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |