| Trial ID: | L5149 |
| Source ID: | NCT06716203
|
| Associated Drug: |
Drug: 5 Mg Bgm0504 Administered Sc
|
| Title: |
A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
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| Acronym: |
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| Status: |
RECRUITING
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| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)
|
| Interventions: |
DRUG: Drug: 5 mg BGM0504 Administered SC|DRUG: Drug: : 10 mg BGM0504 Administered SC|DRUG: Drug: Placebo Administered SC
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c), Change from baseline in HbA1c after 32 weeks of treatment., Week 0 to Week 32 | Secondary: Change From Baseline in Body Weight, Change from baseline in body weight after 52 weeks of treatment., Week 0 to Week 52|Change From Baseline in Hemoglobin A1c (HbA1c), Change from baseline in HbA1c after 52weeks of treatment., Week 0 to Week 52|Percentage of Participants With HbA1c Target Value of <7%, Percentage of Participants With HbA1c Target Value of \<7% after 52weeks of treatment., Week 0 to Week 52|Percentage of Participants With HbA1c Target Value of <5.7%, Percentage of Participants With HbA1c Target Value of \<5.7%after 52weeks of treatment., Week 0 to Week 52|Change From Baseline in Fasting Serum Glucose, Change from baseline in FPG after 52 weeks of treatment., Week 0 to Week 52
|
| Sponsor/Collaborators: |
Sponsor: BrightGene Bio-Medical Technology Co., Ltd. | Collaborators: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
207
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2024-12-02
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| Completion Date: |
2026-08-25
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| Results First Posted: |
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| Last Update Posted: |
2025-02-07
|
| Locations: |
Peking University People's Hospital, Beijing, Beijing, 100044, China
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| URL: |
https://clinicaltrials.gov/show/NCT06716203
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