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New treatment option for Type 2 Diabetes (T2DM)
Official title A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
ClinicalTrials.gov ID: NCT07064486
What this study is testing
What is BGM0504?
BGM0504 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type 2 diabetes (t2dm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- ○ 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...
- Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
- Be of stable weight (± 5%) for at least 3 months before screening;
- Have HbA1c between ≥7.5% and ≤11.0% at screening
You likely can't join if
- ○ Previous diagnosis of type 1 diabetes, special type diabetes;
- Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated...
- Have the acute or chronic pancreatitis;
- Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease...
- Have a serious mental illness or speech impediment and be unable to fully understand the study;
- Suspected or confirmed history of alcohol or drug abuse;
See the full eligibility 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 squared (kg/m²) at screening;
- Be of stable weight (± 5%) for at least 3 months before screening;
- Have HbA1c between ≥7.5% and ≤11.0% at screening
- ○ Previous diagnosis of type 1 diabetes, special type diabetes;
- Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated for an underlying malignancy;
- Have the acute or chronic pancreatitis;
- Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening;
- Have a serious mental illness or speech impediment and be unable to fully understand the study;
- Suspected or confirmed history of alcohol or drug abuse;
- Have had a history of ≥2 severe hypoglycemic episodes in the past 1 year;
- Other conditions that may impact the assessment of investigational products, as determined by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Depok, West Java, Indonesia
- Jakarta, Indonesia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Depok, West Java, Indonesia; Jakarta, Indonesia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.