Type 2 Diabetes (T2DM)
Conditions
Brief summary
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
DRUGBGM0504
Administered SC
DRUGSemaglutide
Administered SC
Sponsors
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Week 0 to Week 24 | Change from baseline in HbA1c after 24 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Week 0 to Week 12 | Change from baseline in HbA1c after 12 weeks of treatment. |
| Change From Baseline in Body Weight | Week 0 to Week 24 | Change from baseline in body weight after 24 weeks of treatment. |
| Percentage of Participants With HbA1c Target Value of <7% | Week 0 to Week 24 | Percentage of Participants With HbA1c Target Value of \<7% after 24 weeks of treatment. |
| Percentage of Participants With HbA1c Target Value of <5.7% | Week 0 to Week 24 | Percentage of Participants With HbA1c Target Value of \<5.7%after 24 weeks of treatment. |
| Change From Baseline in Fasting Serum Glucose | Week 0 to Week 24 | Change from baseline in FPG after 24 weeks of treatment. |
Countries
Indonesia
Contacts
Primary ContactTahapary
Outcome results
None listed