Type 2 Diabetes Mellitus
Conditions
Interventions
PART A HTD1801 500 mg capsule:2 capsules of HTD1801 (250 mg/capsule) ,oral , BID,4 weeks of continuous administration
PART A HTD1801 750 mg capsule:3 capsules of HTD1801 (250 mg/capsule) ,oral , BID,4 weeks of continuous administration
PART A HTD1801 1000 mg capsule:4 capsules of HTD1801 (250 mg/capsule) ,oral , BID,4 weeks of continuous administration
PART A HTD1801 placebo :4 capsules of HTD1801 placebo (250 mg/capsule) ,oral , BID,4 weeks of continuous administration
PART B HTD1801 1000 mg:4 capsules of HTD1801 (250 mg/capsule) ,oral , BID,4 weeks of continuous administration
PART B HTD1801 placebo :4 capsules of HTD1801 placebo (250 mg/capsule) ,oral , BID,4 weeks of continuous administration
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form (ICF) prior to the study and be fully aware of the contents of the study, study process, and adverse reactions that may arise; 2.Be able to complete the study as per the study protocol; 3.The subject and his/her sexual partner are willing to take effective contraceptive measures (as detailed in Appendix 5 in the protocol, version 1.0) from screening until 90 days after the last dose of investigational drug; 4.Aged 18–75 years (inclusive) when signing the ICF, male or female; 5.A body weight not lower than 50 kg for male subjects and not lower than 45 kg for female subjects at screening. Body mass index (BMI) = Body weight (kg)/Body height2 (m2), BMI = 18 kg/m^2; 6.Diagnosis of T2DM according to the 1999 World Health Organization (WHO) criteria: Part A: T2DM treatment-naive subjects who responded poorly to dietary and exercise therapies; T2DM treatment-naive subjects: 1) no treatment with any hypoglycemic drug prior to screening; or 2) no regular treatment with any hypoglycemic drug prior to screening, i.e., prior treatment with hypoglycemic drugs, but for no more than 2 weeks cumulatively in the past 3 months, and no treatment with hypoglycemic drugs (including Chinese herbal medicines, botanical drugs, and Chinese patent medicines with hypoglycemic indications) within 30 days prior to screening; Part B: Subjects who had been treated with stable doses of metformin for no less than 3 months at screening. Subjects must provide proof of a diabetes diagnosis and evidence of metformin use starting 3 months prior to screening (laboratory test reports, outpatient/inpatient medical records, proof of purchase, etc.); 7.7.0 mmol/L <= fasting plasma glucose <= 13.3 mmol/L and 7.5% <= HbA1c <= 11.5% at screening; 8.Diagnosis of fatty liver by ultrasound.
Exclusion criteria
Exclusion criteria: Subject who met any one of the following criteria were ineligible for participation in the study: 1.Allergic constitution (multiple drug and food allergies) or allergies to the active ingredient or excipients of the investigational drug as suspected by the investigators; 2.History of gastrointestinal or other digestive system-related surgery (such as cholecystectomy) within one year prior to screening, history of other surgery within 6 months prior to screening that may affect the study, or planned surgical treatment within 3 months after enrollment; 3.Loss of massive blood (> 400 mL), receipt of blood transfusion, or use of any blood product within 3 months prior to screening; 4.Heavy alcohol consumption within 30 days prior to screening (drinking > 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 5.History of drug abuse or dependence within one year prior to screening; 6.Vaccination within 30 days prior to screening or planned vaccination during the study (except inactivated vaccines); 7.History of glucose-6-phosphate dehydrogenase (G6PD) deficiency at screening (known through inquiry); 8.Concomitant diabetic complications at screening, e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar state, chronic kidney disease, diabetic retinopathy, etc; 9.Recurrent episodes of hypoglycemic events, e.g., >= 2 episodes of grade 3 hypoglycemic events within 3 months prior to screening; 10.Unstable angina at screening, and/or history of myocardial infarction, heart failure, percutaneous coronary intervention, coronary artery bypass grafting, stroke, or other diseases within 12 months prior to screening; left ventricular ejection fraction (LVEF) 10 mIU/L; 13.Concurrent severe circulatory, digestive, respiratory, urinary, hematological, immune, psychiatric/neurological, or other system disorders; history of neurological/psychiatric disorders or on medication for these disorders; history of malignant tumors, or plan to receive radiotherapy, cytotoxic chemotherapeutic agents, or immunosuppressant drugs at screening; 14.Use of any UDCA-containing or BBR-containing chemical drugs or traditional Chinese medicine preparations within 30 days prior to screening; 15.Use of any drugs that may affect blood glucose level within 30 days prior to screening, such as systemic glucocorticoids (except hormone replacement therapy at stable doses for not less than 3 months), growth hormones, non-selective ß-receptor blockers (e.g., propranolol), thiazide diuretics at a dose of > 25 mg/day, aspirin at a dose of > 300 mg/day, Chinese herbal medicine, etc; 16.Use of non-oral antibiotics (except for topical use) within 30 days prior to screening or current trauma or infection requiring antimicrobial treatment. 17.Participation in any clinical trials of other investigational drugs or medical devices (in which subjects received such drugs or used these medical devices), or use of any unapproved treatment within 30 days prior to screening; 18.Current use of any chemical drugs, traditional Chinese medicine preparations, or dietary supplements for weight loss, partici
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Vital signs (blood pressure, pulse, and body temperature);Clinical laboratory tests (Metabolic panel, complete blood count, urinalysis, and coagulation) ;12 lead ECG;Plasma glucose, insulin, C-peptide, and glycosylated hemoglobin (HbA1c);Low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and total cholesterol (TC);Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and total bilirubin (TBIL); | — |
Countries
China
Contacts
Public ContactYanHua Ding;GuiXia Wang
The First Hospital of Jilin University
Outcome results
None listed