A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
Recruiting
Phase 3
Interventional Study
Type 2 Diabetes (T2DM)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 477 (estimated)
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd. · Industry
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About This Trial
This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* ○ Have been diagnosed with type 2 diabetes mellitus (T2DM);
* Be on stable treatment with unchanged dose of metformin ≥1500 mg/day or \<1500 mg/day but ≥1000 mg/day (the maximum tolerated dose) for at least 8 weeks prior to screening
* Have a BMI ≥23 kilograms per meter s…
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