A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BGM0504, BGM0504, Semaglutide.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes (T2DM). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Open Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Overview
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
Interventions
- Drug BGM0504
Administered SC - Drug BGM0504
Administered SC - Drug Semaglutide
Administered SC
Primary outcome measures
- Change From Baseline in Hemoglobin A1c (HbA1c) [Time frame: Week 0 to Week 24]
Secondary outcome measures (5)
- Change From Baseline in Hemoglobin A1c (HbA1c) [Time frame: Week 0 to Week 12]
- Change From Baseline in Body Weight [Time frame: Week 0 to Week 24]
- Percentage of Participants With HbA1c Target Value of <7% [Time frame: Week 0 to Week 24]
- Percentage of Participants With HbA1c Target Value of <5.7% [Time frame: Week 0 to Week 24]
- Change From Baseline in Fasting Serum Glucose [Time frame: Week 0 to Week 24]
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 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
Exclusion criteria
- ○ 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Indonesia · 4 centers
- RS Universitas Indonesia — Depok
- RSUP Fatmawati — Jakarta
- RSUP Persahabatan — Jakarta
- RSUPN Dr. Cipto Mangunkusumo — Jakarta
Identifiers
NCT: NCT07064486 · BGM0504-Ⅲ-T2DM-02-IDN