Status:
COMPLETED
A Study of HS-20094 in T2DM Participants
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief Summary
This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semagl...
Eligibility Criteria
Inclusion
- Male or female subjects,20-65 years of age at the time of signing informed consent.
- Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit.
- Treated with conventional lifestyle intervention and stable treatment with metformin ( ≥ 1000 mg/day) at least 3 months prior to screening HbA1c 7.5-10%(both inclusive)at screening visit.
Exclusion
- A history of type 1 diabetes, specific diabetes, or secondary diabetes.
- Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
- Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening.
- A history of grade 2 hypoglycemia(blood glucose 3.0 mmol/L)or grade 3 hypoglycemia(hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery)within 6 months before screening.
- Diabetid ketoacidosis or hyperosmolar coma or lactic acidosis requiring hospitalization occurred within 6 months before screening.
- Severe infection such as diabetic foot infection, pneumonia, or sepsis within 30 days before screening.
- Uncontrollable hypertension.
- History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Pregnant or lactating woman.
- In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Key Trial Info
Start Date :
May 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06118008
Start Date
May 31 2023
End Date
January 4 2024
Last Update
August 3 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China