A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
Recruiting · NCT07064486 · Interventional (participants receive a specific treatment) · Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
4 locations listed.
- RSUP Fatmawati - Jakarta, Indonesia
- RSUP Persahabatan - Jakarta, Indonesia
- RSUPN Dr. Cipto Mangunkusumo - Jakarta, Indonesia
- RS Universitas Indonesia - Depok, West Java, Indonesia