Health TrialsbyHealthPanel

A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

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 is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.

The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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%；

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

    Drug: BGM0504 Administered SC

  • Drug: : 10 mg BGM0504 Administered SC

    Drug

    Drug: BGM0504 Administered SC

  • Drug: Placebo Administered SC

    Drug

    Drug: Placebo Administered SC

Treatment groups

207 Participants
are divided into 3 treatment groups
Group A: Experimental: 5 mg BGM0504Experimental treatment 1 intervention
Group B: Experimental: 10 mg BGM0504Experimental treatment 1 intervention
Group C: Placebo Comparator: PlaceboPlacebo 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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