Health TrialsbyHealthPanel

A Study of BGM0504 in Participants with Type 2 Diabetes

ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBrightGene Bio-Medical Technology Co., Ltd.

About this trial

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

■ Have been diagnosed with type 2 diabetes mellitus (T2DM);

Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (< 1500mg but≥1000mg daily) for 8 weeks before screening； 2)Metformin treatment dose <1500mg/day at Screening and have not reached the maximum tolerated dose ；3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.

Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;

Be of stable weight (± 5%) for at least 3 months before screening;

Disqualifiers

■ Previous diagnosis of type 1 diabetes, special type diabetes;

There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).

Have had chronic or acute pancreatitis any time prior to study entry;

Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug: 5 mg BGM0504 Administered SC

    Drug

    Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

  • Drug:10 mg BGM0504 Administered SC

    Drug

    Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.

  • Drug: Semaglutide Administered SC

    Drug

    Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week

Treatment groups

537 Participants
are divided into 3 treatment groups
Group A: Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.Experimental treatment 1 intervention
Group B: Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.Experimental treatment 1 intervention
Group C: Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a weekActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Hemoglobin A1c (HbA1c)

Change from baseline in HbA1c after 32 weeks of treatment.

Time frame
Week 0 to Week 32

Secondary outcomes

1

Change From Baseline in Body Weight

Change from baseline in body weight after 52 weeks of treatment.

Time frame
Week 0 to Week 52
2

Change From Baseline in Hemoglobin A1c (HbA1c)

Change from baseline in HbA1c after 52weeks of treatment.

Time frame
Week 0 to Week 52
3

Percentage of Participants With HbA1c Target Value of <7%

Percentage of Participants With HbA1c Target Value of \<7% after 52weeks of treatment.

Time frame
Week 0 to Week 52
4

Percentage of Participants With HbA1c Target Value of <5.7%

Percentage of Participants With HbA1c Target Value of \<5.7%after 52weeks of treatment.

Time frame
Week 0 to Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrightGene Bio-Medical Technology Co., Ltd.

Lead sponsor

BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

Collaborator

Source ClinicalTrials.gov
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