| Trial ID: | L4989 |
| Source ID: | NCT06202079
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| Associated Drug: |
Gzr4 Injection
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| Title: |
A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: GZR4 Injection|DRUG: Insulin Degludec
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| Outcome Measures: |
Primary: Change in HbA1c, Change from baseline in HbA1c after 16 weeks of treatment, From baseline (week 0) to week 16 | Secondary: Change in fasting plasma glucose(FPG), Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment, From baseline (week 0) to week 16|Weekly doses of GZR4 Injection/Insulin Degludec, Weekly doses of once-weekly GZR4 Injection and once-daily Insulin Degludec Injection from week 15 to week 16 are presented., Week 15-16|Incidence and Rate of Treatment-emergent adverse events (TEAEs), A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period., From baseline (week 0) to week 20|Incidence and Rate of hypoglycemia episodes, 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 blood glucose (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., From baseline (week 0) to week 20|Change in ADA of GZR4, Blood samples will be analysed for anti-GZR4 antibodies, From baseline (week 0) to week 16|Change in Nab of GZR4, Blood samples will be analysed for Nab, From baseline (week 0) to week 16
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| Sponsor/Collaborators: |
Sponsor: Gan and Lee Pharmaceuticals, USA
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
179
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2023-08-11
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| Completion Date: |
2024-08-08
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| Results First Posted: |
|
| Last Update Posted: |
2025-01-23
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| Locations: |
Study Site 07, Wuhan, Hubei, China|Study Site 06, Changzhou, Jiangsu, China|Study Site 08, Jinan, Shandong, China|Study Site 04, Zibo, Shandong, China|Study Site 03, Xi'an, Shanxi, China|Study Site 02, Beijing, China|Study Site 05, Beijing, China|Study Site 01, Tianjin, China
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| URL: |
https://clinicaltrials.gov/show/NCT06202079
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