Clinical trial
A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia
Recruiting now · Phase 3 · 1 countries · Registry ID NCT07064486
Recruiting nowPhase 3Interventional
What this study 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
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes (T2DM)
Full registry 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.
Treatments and study arms
BGM0504
Drug
Administered SC
BGM0504
Drug
Administered SC
Semaglutide
Drug
Administered SC
Primary outcomes
Change From Baseline in Hemoglobin A1c (HbA1c)Week 0 to Week 24
Change from baseline in HbA1c after 24 weeks of treatment.