A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug: 5 mg BGM0504 Administered SC, Drug: : 10 mg BGM0504 Administered SC, Drug: Placebo Administered SC.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone
Overview
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.
Interventions
- Drug Drug: 5 mg BGM0504 Administered SC
Drug: BGM0504 Administered SC - Drug Drug: : 10 mg BGM0504 Administered SC
Drug: BGM0504 Administered SC - Drug Drug: Placebo Administered SC
Drug: Placebo Administered SC
Primary outcome measures
- Change From Baseline in Hemoglobin A1c (HbA1c) [Time frame: Week 0 to Week 32]
Secondary outcome measures (5)
- Change From Baseline in Body Weight [Time frame: Week 0 to Week 52]
- Change From Baseline in Hemoglobin A1c (HbA1c) [Time frame: Week 0 to Week 52]
- Percentage of Participants With HbA1c Target Value of <7% [Time frame: Week 0 to Week 52]
- Percentage of Participants With HbA1c Target Value of <5.7% [Time frame: Week 0 to Week 52]
- Change From Baseline in Fasting Serum Glucose [Time frame: Week 0 to Week 52]
Eligibility criteria
Inclusion criteria
- ☑ 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%；
- Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.
Exclusion criteria
- ■ 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;
- Mentally incapacitated or speech-impaired;
- Suspected or confirmed history of alcohol or drug abuse;
- Pregnant or lactating woman;
- The investigator considers that there are any other conditions that make it inappropriate to participate in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06716203 · BGM0504-Ⅲ -T2DM-01