Type 2 Diabetes
Conditions
Interventions
Experimental group:Mulberry twig alkaloids tablets
Sponsors
Shanghai Sixth People's Hospital
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) When signing the informed consent form, the age is = 18 years old, and there is no gender limit; 2) Diagnosed as type 2 diabetes according to WHO diagnostic criteria; 3) HbA1c level of 7.0–10.0%, and fasting blood glucose (FBG) <13 mmol/L 4) Single drug treatment cases: type 2 diabetes patients who have not used hypoglycemic drugs at the time of screening, or who have used hypoglycemic drugs irregularly within 3 months before screening (the cumulative use of hypoglycemic drugs in the past 3 months does not exceed 2 weeks and has not used hypoglycemic drugs in the past 1 month), who have controlled their blood sugar for more than 3 months through diet and exercise, and whose blood sugar control is poor; Combined treatment cases: during screening, patients with type 2 diabetes who received at least daily antidiabetic drugs with a stable daily dose = 6 weeks (limited to single drug treatment of Metformin, sulfonylureas, DPP-4 inhibitors or basic insulin, or dual treatment containing Metformin and the above drugs), and whose blood sugar was poorly controlled, of which the total daily dose of Metformin was not less than 1500mg 5) Be able to understand the procedures and methods of this clinical trial, with full informed consent, voluntary participation by the patient and signed by the patient himself or a guardian or fair witness.
Exclusion criteria
Exclusion criteria: 1) Allergy or intolerance to a-glucosidase inhibitors; 2) Ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic coma have occurred within the last 6 months, requiring hospitalization; 3) A severe hypoglycemic event of unknown cause within the last 6 months (requiring someone else to help with recovery); Or frequent hypoglycemia: such as more than 2 hypoglycemic events (blood sugar =3.9mmol/L) within 1 month before screening; 4) Patients with liver disease: liver function ALT or AST > 3×ULN or TBil > 2×ULN 5) Patients with kidney disease: glomerular filtration rate 1.5×ULN 6) Fasting C-peptide < 0.333 ng/mL (111 pmol/L) (if the patient combined with basal insulin is not subject to the above restrictions) 7) Poor blood pressure control (systolic blood pressure (SBP) =160mmHg and/or diastolic blood pressure (DBP) =100 mmHg) 8) A history of drug use or alcohol dependence [drinking more than 21 units (men) or 14 units (women) of alcohol per week (1 unit is about 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine)] 9) Patients with chronic gastrointestinal dysfunction with obvious digestive and absorption disorders; 10) Patients with any unstable or blood-sugar-related endocrine system diseases (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.) or immune system diseases requiring treatment are judged by the investigator to be unsuitable for the trial; 11) History of heart failure (NYHA Class III or ?), or history of acute myocardial infarction or unstable angina pectoris in the 6 months prior to screening; Have a history of coronary angioplasty, coronary stenting, or coronary bypass surgery within 6 months prior to screening, or have a recent heart surgery plan; Or prolonged QTc interval =500 ms; 12) A history of diseases that may cause hemolysis or erythrocyte instability affecting the HbA1c test, such as hemoglobin diseases (e.g. Sickle cell anemia or thalassemia, sideroblastic anemia); 13) Patients with medical conditions that may be aggravated by flatulence (e.g., Roemheld syndrome, severe hernia, intestinal obstruction, bowel surgery and intestinal ulcers); 14) Have any type of malignant tumor (whether cured or not); 15) Have participated in clinical trials of other scientific research drugs or medical devices within 1 month before signing the informed consent, and have received treatment with experimental drugs or devices; 16) Pregnancy, during the trial women who are planning to become pregnant or breastfeeding, or eligible subjects (male and female) who are fertile do not consent to the use of reliable contraceptive methods during the trial and for at least 1 month after the last dosing; 17) The investigators believe that there are circumstances in which it is not appropriate to participate in this trial, such as the efficacy cannot be evaluated or the expected course of treatment and follow-up are unlikely to be completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin;Clinically significant changes in vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood-glucose;Weight;Blood fat;HOMA-ß;HOMA-IR;MBCI;C-peptide;Insulin;Postprandial blood-glucose;Adverse Event;Serious Adverse Event;Clinical significance of laboratory indicators; | — |
Countries
China
Contacts
Public ContactWeiping Jia/Xinhua Xiao
Shanghai Sixth People's Hospital Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed