type 2 diabetes
Conditions
Interventions
single arm:Mulberry Branch Total Alkaloid Tablets
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-70 years old (including boundary values), both male and female; 2) Diagnosed with type 2 diabetes according to WHO diagnostic criteria; 3) Patients who can use total alkaloid tablets of mulberry branch according to clinical conditions; 4) 7% <= HBA1c <=10%, and fasting venous blood glucose <=11.1mmol/L; 5) Monotherapy cases: Type 2 diabetes patients who have not used hypoglycemic drugs at the time of screening, or have used hypoglycemic drugs irregularly in the 3 months before screening (the cumulative use of hypoglycemic drugs in the past 3 months is less than 2 weeks and no hypoglycemic drugs in the past 1 month), and have controlled blood glucose through diet and exercise for more than 3 months, and have poor blood glucose control; 1.Combined treatment cases: Patients with type 2 glycosuria who had received at least 2 weeks of stable daily dose of other oral hypoglycemic drugs for poor blood glucose control during screening were given this product in addition to the basic regimen, or patients who were intolerant to other oral hypoglycemic drugs during blood glucose control were replaced with this product; 6) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and were followed up.
Exclusion criteria
Exclusion criteria: 1) Clinically diagnosed as type 1 diabetes mellitus; 2) Those who are allergic to the ingredients contained in this product or have been sensitized to a-glycosidase inhibitors in the past; 3) Suffering from systemic diseases such as systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, myasthenia gravis, etc. 4) ketoacidosis, diabetic lactic acid poisoning or hyperosmolar non-ketotic coma occurred within the last 6 months, requiring hospitalization; 5) Liver disease, liver function ALT or AST > 3×ULN or TBil > 2×ULN; 6) In patients with kidney disease, glomerular filtration rate 1.5×ULN; 7) Patients with chronic gastrointestinal dysfunction with obvious digestive and absorption disorders, and other endocrine diseases: hyperthyroidism, hypercortisolism, acromegaly, etc. 8) Patients with gastrointestinal diseases (such as Roemheld syndrome, severe hernia, intestinal obstruction, postoperative bowel surgery, and intestinal ulcers) that may be aggravated by flatulence; 9) 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; 10) Patients with acute complications of diabetes (such as ketoacidosis, hyperosmolar hyperglycemic dizziness, lactic acidosis, etc.) or serious chronic complications (diabetic retinopathy stage IV and above or diabetic nephropathy stage IV and above); 11) Severe hypoglycemic events with unknown causes have occurred within the last 6 months (need help from others to recover);Or frequent hypoglycemia: such as two or more hypoglycemic events (blood sugar <=3.9mmol/L) within 1 month before screening; 12) Suffering from serious diseases of vital organs, including but not limited to cardiovascular, lung, liver, kidney, or other uncontrollable diseases; 13) 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; 14) 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); 15) Have any type of malignant tumor (cured or not); 16) Participated in clinical trials of other scientific drugs or medical devices within 1 month before signing the informed consent; 17) Alcohol or drug users;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c/1 hour post meal blood glucose;Intravenous blood sugar 1 hour after a meal; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting venous glucose;Fasting c-peptide;Fasting insulin;Insulin 1 hour after meal;C-peptide 1 hour after meal;Venous blood sugar 2 hours after a meal;Insulin 2 hours after a meal;C-peptide 2 hours after meal;waistline;Hip circumference;height;weight;total cholesterol, TC;triglyceride, TG;High-density lipoprotein cholesterol, HDL-C;Low density lipoprotein cholesterol, LDL-C;HOMA-ß;HOMA-IR;MBCI;electrocardiogram;Blood routine examination;urinalysis;Blood biochemistry;Pregnancy test;Proportion of subjects with adverse reactions;Adverse events, abnormal changes in clinical symptoms and signs before and during treatment, abnormal changes in laboratory test indicators before and during treatment; | — |
Countries
China
Contacts
Public ContactLi Huifang
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed