Type 2 Diabetes
Conditions
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 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.
Interventions
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients 18 to 75 years of age, inclusive 2. Patients were diagnosed with T2DM for at least 3 months before screening. 3. 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 4. Body mass index (BMI）≥ 22 kg/m2.
Exclusion criteria
1. Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator 2. Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening 3. 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 4. Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening 5. 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) 6. Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of HbA1c in the patients | From baseline to week 32 |
Secondary
| Measure | Time frame |
|---|---|
| The change in fasting blood glucose | From baseline to week 32 |
| The change in C peptide | From baseline to week 32 |
| The change of fasting insulin in the patients | From baseline to week 32 |
| The change in body weight | From baseline to week 32 |
| The percentage of patients reaching the HbA1c target of<7.0% | From baseline to week 32 |
| The percentage of patients with 5% or greater body weight loss | From baseline to week 32 |
| The percentage of patients reaching the HbA1c target of ≤ 6.5% | From baseline to week 32 |
Countries
China
Outcome results
None listed