Diabetes Mellitus Type 2
Conditions
Brief summary
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with T2DM. This study includes three multiple-ascending dose cohorts.
Interventions
Participants received THDBH120 by subcutaneous injection.
Participants received placebo by subcutaneous injection.
Sponsors
Tonghua Dongbao 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 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients 18 to 75 years of age, inclusive; * Have T2DM for at least 6 months before screening based on the disease diagnostic criteria (World Health Organization \[WHO\] Classification for Diabetes); * Treated with diet and exercise alone, or a stable dose of metformin (≥1000 mg/day and not more than the locally approved dose) for at least 2 months prior to screening; * Have a BMI between 23 and 35 kg/m²(inclusive) at screening; * HbA1c levels: 7.0% to 10.0% (inclusive) for subjects treated by diet or exercise alone; 7.0% to 9.0% (inclusive) for subjects receiving stable-dose metformin.
Exclusion criteria
* Have been diagnosed with proliferative diabetic retinopathy, diabetic maculopathy, or non-proliferative diabetic retinopathy requiring treatment during the study; * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia type 2; * Have diagnosed hyperthyroidism or hypothyroidism; * Have grade 2 hypoglycemia events or grade 3 hypoglycemia events within 6 months prior to screening; * Have a history of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 6 months prior to screening; * Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; * Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, \>470 ms for females), PR interval \>200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia); * Weight change ≥ 5% within 3 months prior to screening; * Have been treated with insulin, excluding insulin therapy for gestational diabetes mellitus, or acute/temporary insulin therapy (≤ 14 days) for conditions such as acute illness, hospitalization, or elective surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) | 78 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120. | Day 1 Pre-dose through Day 43 |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120 | Day 1 Pre-dose through Day 43 |
| Change From Baseline in HbA1C | 43 days |
| Number of Participants With Anti-THBHD120 Antibodies | 78 days |
Countries
China
Outcome results
None listed