CompletedPhase 2

UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study

China211 participantsStarted 2025-03-22

Plain-language summary

The purpose of this study is to evaluate the efficacy of UBT251 injection after 24 weeks of continuous administration in patients with type 2 diabetes mellitus and to recommend the dosing regimen for the Phase III clinical trial.

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕. Any antihyperglycemic agent other than metformin within 3 months before screening, including GLP-1 analogues, oral antidiabetics, insulin, Chinese herbal medicines or health products with glucose-lowering effects.
✕. Systemic glucocorticoids, growth hormone, or any drug that may affect glucose metabolism within 3 months before screening.
✕. Any weight-loss medication within 3 months before screening.
✕. Diabetes other than type 2 (e.g., type 1 diabetes, specific types of diabetes).
✕. Acute or chronic pancreatitis, or history of pancreatic surgery.
✕. Symptomatic gallbladder disease within 2 years before screening (imaging-confirmed gallstones with physician-diagnosed related abdominal pain); subjects with prior cholecystectomy without sequelae may be included.
✕. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
✕. Hematologic disorders that may interfere with HbA1c measurement or increase subject risk, or any disease causing hemolysis or red-cell instability.

What they're measuring

Change From Baseline in HbA1c at Week 24

Timeframe: Baseline to week 24

Trial details

NCT IDNCT07163624

SponsorThe United Bio-Technology (Hengqin) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-21

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus (T2DM) trials