A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Recruiting
Phase 3
Interventional Study
Type 2 Diabetes Mellitus (T2DM)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 207 (estimated)
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd. · Industry
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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 diabete…
Trial Locations
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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) ≤ …
Contacts
Linong Ji,MD, chief physician, Peking University People's Hospital
+86 13910978815
CONTACT