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 metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
275
Administrated by subcutaneous injection once a week
Administrated by subcutaneous injection once a week
Administrated by subcutaneous injection once a week
Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)
Tianjin, Tianjin Municipality, China
The change of HbA1c in the patients
Time frame: From baseline to week 32
The percentage of patients reaching the HbA1c target of ≤ 6.5%
Time frame: From baseline to week 32
The percentage of patients reaching the HbA1c target of<7.0%
Time frame: From baseline to week 32
The change in fasting blood glucose
Time frame: From baseline to week 32
The change in C peptide
Time frame: From baseline to week 32
The change of fasting insulin in the patients
Time frame: From baseline to week 32
The change in body weight
Time frame: From baseline to week 32
The percentage of patients with 5% or greater body weight loss
Time frame: From baseline to week 32
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