A Phase 3 Study of HS-20094 in Patients With T2DM
ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.
Eligibility criteria
Qualifiers
Males and females, Age ≥18 years at the time of signing informed consent.
Stable daily dose(s) for ≥90 days prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;
Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
BMI ≥ 23 kg/m2.
Disqualifiers
Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).
Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；
Trial design
Treatments tested in this trial
- HS-20094 Injection
- Dulaglutide Injection
Treatment groups
546 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov