Type 2 Diabetes
Conditions
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 Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. HS-20094 and placebo were administered in a double-blind design by subcutaneous injection once a week for a total of four times, and the dose was gradually increased weekly (2.5-2.5-5-5 mg, 5-510-10 mg, 5-10-15-15 mg, 5-10-15-20 mg). The active control drug semaglutide was administered by open-label, titrated subcutaneous injection once a week for a total of four times, and the dose was increased gradually every week until 1.0 mg (0.25-0.5-0.5-1.0 mg). The primary study objective was to 1) Evaluate the safety and tolerability of multiple subcutaneous injections of HS-20094 in subjects with type 2 diabetes mellitus (T2DM) with or without overweight or obesity;2) Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of multiple subcutaneous injections of HS-20094.
Interventions
DRUGHS-20094 5mg
Administrated by subcutaneous injection
DRUGHS-20094 10mg
Administrated by subcutaneous injection
DRUGHS-20094 15mg
Administrated by subcutaneous injection
DRUGHS-20094 20mg
Administrated by subcutaneous injection
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
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature | From Baseline to Day 57 | Vital signs |
| The changes ECG examination assessed by PR, R-R, QRS and QTcF | From Baseline to Day 57 | 12-lead electrocardiogram (ECG) parameters |
| The changes in Blood pressure | From Baseline to Day 57 | Vital signs |
| Pulse rate | From Baseline to Day 57 | Vital signs |
| Respiratory rate | From Baseline to Day 57 | Vital signs |
| Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug | From Baseline to Day 57. | A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module |
| The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function | From Baseline to Day 57 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Tmax of HS-20094 | Baseline to Day 57 | PK: Tmax of HS-20094 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094 | Baseline to Day 57 | PK: AUC of HS-20094 |
| Pharmacodynamics (PD): HbA1c | Baseline to Day 29 | PD: change of HbA1c |
| Pharmacokinetics (PK): Cmax of HS-20094 | Baseline to Day 57 | PK: Cmax of HS-20094 |
Countries
China
Outcome results
None listed