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Completed
NCT06411275
A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise
Conditions: Type 2 Diabetes Mellitus
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 113
Sponsor: Shenzhen HighTide Biopharmaceutical Ltd.
Location: Peking University People's Hospital Beijing
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.
Eligibility Criteria
Key Inclusion Criteria:
* Have been diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria
* Have followed dietary and exercise interventions for at least 8 weeks prior to screening
* Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization)
* Have fasting plasma glucose \
Source: ClinicalTrials.gov (NCT06411275). StuddyBuddy aggregates publicly available trial information.
