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Recruiting
NCT07659574
Phase III Study of UBT251 Injection in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Diet and Exercise Alone（UNIGUIDE-1）
Conditions: Type 2 Diabetes
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 360
Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.
Location: The Second Xiangya Hospital of Central South University Changsha Hunan
Summary
This multicenter, randomized, double-Blind, parallel-group, placebo-controlled phase III trial is to evaluate the efficacy and safety of UBT251 Injection in patients with Type 2 Diabetes Mellitus with inadequate glycemic control on diet and exercise alone
Eligibility Criteria
Inclusion Criteria:
1. Aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of gender;
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months in accordance with the 2019 World Health Organization (WHO) criteria;
3. Managed solely through diet and exercise intervention (without the use of any glucose-lowering medications) for at least 3 months prior to screening;
4. Glycated hemoglobin (HbA1c) level ≥7.5% and ≤10.5% at screening;
5. Body mass index (BMI) ≥23.0 kg/m² at screening, and stable body weight (change \
Source: ClinicalTrials.gov (NCT07659574). StuddyBuddy aggregates publicly available trial information.
