Type 2 Diabetes Mellitus
Conditions
Interventions
experimental group:Treatment period: 0-24 weeks, Mulberry Twig Alkaloid Tablet + Acarbose Tablet simulator
control group:Treatment period: 0-24 weeks, Mulberry Twig Alkaloid Tablet simulator + Acarbose Tablet
Sponsors
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Body mass index 19kg/m2 to 30 kg/m2; 3. Diagnosed as type 2 diabetes according to the diagnostic criteria of type 2 diabetes established by WHO in 1999; 4. Single drug treatment case: patients with type 2 diabetes who had not received antidiabetic drug treatment within 3 months before screening and received antidiabetic drug treatment at any time in the past did not exceed 3 months, and had been treated with diet control and exercise for more than 3 months. Poor blood glucose control in patients with type 2 diabetes; Cases treated with metformin: patients who had not received non-biguanide antidiabetic drugs within 3 months before screening, and received biguanide antidiabetic drugs with stable condition and drug dose for more than 8 weeks and poor blood glucose control; 5. HbA1c 7% to 10%, and fasting venous plasma glucose <=13 mmol/L; 6. Be able to understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The difference of fasting blood glucose level before and after the introduction period was more than 2.5mmol/l (fingertip blood glucose); 2. Those who had been treated with a-glycosidase inhibitors were ineffective, allergic or intolerant, 3. Those with severe diabetic complications; 4. Hyperlipidemia patients with irregular or unstable dose of lipid-lowering drugs 5. Chronic gastrointestinal disorders with obvious digestive and absorption disorders, as well as other endocrine diseases, such as hyperthyroidism, cortisol, acromegaly, etc.; 6. Patients with diseases that may worsen due to intestinal flatulence (such as Roemheld syndrome, severe hernia, intestinal obstruction, intestinal surgery and intestinal ulcers); 7. Serious heart disease, myocardial infarction, unstable angina pectoris and chronic cardiac insufficiency (NYHA grade III and IV); 8. Subjects (taking or not taking antihypertensive drugs) had poor blood pressure control (SBP = 160mmhg, or DBP = 100mmhg); 9. liver disease, ALT or AST > 2 ULN, or TBIL > 2 ULN, and the diagnosis was confirmed within one week; 10. Patients with renal function impairment (Cr > 1 ULN or Ccr < 60ml / min) and confirmed by reexamination within one week; 11. Combined use of drugs that affect glucose metabolism, such as glucocorticoids; 12. Combined use of Chinese herbal medicine with the effect of regulating blood glucose within three months, 13. Those who have serious diseases and may be in danger of life during treatment and follow-up; 14. Mental and neurological disorders, unable to correctly express their wishes; 15. Alcoholics and drug abusers and addicts; 16. Women of childbearing age are pregnant, breastfeeding, have pregnancy intentions or have a positive pregnancy test (urine HCG or blood HCG), and should not take effective contraceptive measures during the trial (effective contraceptive measures include sterilization, intrauterine device, oral contraceptive or diaphragm method prescribed by local law); 17. Patients who have participated in clinical trials of other drugs or medical devices in the past three months; 18. Patients with other diseases that the researchers believe will not be able to evaluate or are unlikely to complete the expected course of treatment and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| the proportion of HbA1c < 6.5% or< 7%;fasting blood glucose(venous plasma, FBG);1 hour postprandial blood glucose (1h-PBG);2 hours postprandial blood glucose (2h-PBG);area under the curve of postprandial blood glucose (AUC0-2h);weight; | — |
Countries
China
Contacts
Public ContactXiaochun Liang
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed