Status:
COMPLETED
A Study of HS-20094 in Patients With T2DM
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable me...
Eligibility Criteria
Inclusion
- Male or female patients 18 to 75 years of age, inclusive
- Patients were diagnosed with T2DM for at least 3 months before screening.
- Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000mg/day and not more than the locally approved dose) for at least 2 months prior to screening
- Body mass index (BMI）≥ 22 kg/m2.
Exclusion
- Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator
- 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 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
- Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening
- Occurrence of any of the following events within 6 months prior to screening: acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), transient ischemic attack, cerebrovascular accident, decompensated congestive heart failure, or Class III or IV heart failure (NYHA classification)
- Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)
Key Trial Info
Start Date :
February 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2025
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06901648
Start Date
February 6 2024
End Date
April 9 2025
Last Update
August 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)
Tianjin, Tianjin Municipality, China