Type 2 diabetes mellitus
Conditions
Interventions
HTD1801 500 mg:2 capsules of HTD1801 (250 mg/capsule) + 2 capsules of placebo, oral administration, BID.
HTD1801 1000 mg :4 capsules of HTD1801 (250 mg/capsule) ,oral administration, BID.
Placebo :4 capsules of placebo, oral administration, BID.
Sponsors
Peking University People 's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Are >=18 years old to <=75 years old when signing the informed consent form 2. Have been diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria 3. Have followed dietary and exercise interventions for at least 8 weeks prior to screening. 4. Have HbA1c =7.5% to =11.0% (screening) and =7.0% to =10.5% (pre-randomization). 5. Have fasting plasma glucose <13.9 mmol/L (screening and pre-randomization) 6. Have a body mass index =18 kg/m2 to =40 kg/m2 7. Agree to maintain the same dietary and exercise habits throughout the study, and are willing and able to use a home blood glucose meter 8. Are able to understand and sign the informed consent forms and comply with the study protocol
Exclusion criteria
Exclusion criteria: 1. Have type 1 diabetes mellitus, or specific diabetes mellitus (such as diabetes mellitus due to pancreatic injury, Cushing's syndrome or acromegaly, etc.) 2. Have had diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to screening 3. Have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening 4. Have had 2 or more Grade 3 hypoglycemic events within 12 months prior to screening 5. Have any disease that may cause hemolysis or erythrocyte instability at screening 6. Have had weight gain or loss =5% from screening to randomization 7. Have a liver stiffness measurement (via transient elastography) >13.0 kPa at screening 8. Have used any chemical or traditional Chinese medicines containing ursodeoxycholic acid (UDCA) or berberine (BBR) within 4 weeks prior to screening 9. Have an allergy to HTD1801, BBR, UDCA, empagliflozin, or excipients included in the formulation of HTD1801 or empagliflozin 10. Have a history of drug abuse or dependence within 12 months prior to screening 11. Have had a refractory urinary tract or genital infection within 6 months prior to screening 12. Have any severe gastrointestinal disease at screening that affects drug absorption, distribution, metabolism, or excretion, including chronic gastrointestinal disease that causes recurrent diarrhea; or have undergone gastrointestinal surgery that affects drug absorption 13. Have continuously used insulin or an insulin analog for more than 14 days within 12 months prior to screening 14. Have used 2 or more classes of hypoglycemic drugs for more than 8 weeks within 12 months 15. Have used any glucose-modifying medications within 8 weeks prior to screening 16. Have used medications (including traditional Chinese medicine) or dietary supplements which may improve or alter hepatic function within 4 weeks prior to screening 17. Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 4 weeks prior to screening 18. Have used antibiotics (except for topical application) within 4 weeks prior to screening 19. Have been taking any probiotic-containing medications or dietary supplements within 4 weeks prior to screening 20. Have used lipid-lowering medications at stable doses within 4 weeks prior at screening 21. Have uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg) at screening and pre-randomization 22. Have uncontrolled abnormal thyroid function, or have a clinically significant abnormality on thyroid function test that requires treatment at screening 23. Have suffered from severe infection (e.g. acute pancreatitis, COVID-19) or severe trauma, or have undergone major surgery within 3 months prior to screening that, in the opinion of the investigator, makes the subject unsuitable for the study 24. Have a history of autoimmune hepatitis, primary biliary cholangitis, alcoholic liver disease, hepatolenticular degeneration, or drug-induced liver injury 25. Have a history of malignant tumors within 5 years prior to screening or are being assessed for potential malignant tumors at screening 26. Are receiving treatment for or have a history of psychiatric diseases that, in the opinion of the investigator, makes the subject unsuitable for the study 27. Have a history of deco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Hypoglycemic events;Clinical laboratory tests (Metabolic panel, complete blood count, urinalysis, and coagulation);12-lead electrocardiogram (ECG);Vital signs (body temperature, pulse, and blood pressure);Physical examination;Changes in blood glucose;Changes in insulin;Changes in C-peptide;Changes in blood lipids;Changes in liver function;Changes in intestinal flora;Population pharmacokinetics;Change in Controlled Attenuation Parameter Values (CAP) Detected by Transient Elastography of the Liver;Change in C-reactive protein;Change in subject weight; | — |
Countries
China
Contacts
Public ContactLinong Ji
Peking University People's Hospital
Outcome results
None listed