Type 2 Diabetes Mellitus
Conditions
Interventions
experimental group:week0-week 16, Mulberry Twig Alkaloid Tablet
control group:week0-week 16, placebo
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. TCM syndrome differentiation is Yin deficiency and heat excess syndrome or dampness heat trapped spleen syndrome; 5. Patients with type 2 diabetes whose blood sugar is not well controlled after diet control and exercise therapy for more than 3 months; 6. HbA1c 7% to 9%, and fasting venous plasma glucose <=11 mmol/L; 7. 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 over 2.5mmol/L (fingertip blood glucose) twice before and after introduction; 2. Screening for having received anti-diabetic drug therapy within 3 months or receiving continuous anti-diabetic drug therapy at any time before screening for more than 3 months; 3. Those who have failed to respond to -glucosidase inhibitor drugs, or are allergic or intolerant; 4. Patients with severe diabetic complications; 5. Patients with hyperlipidemia who take lipid-lowering drugs in irregular or unstable doses; 6. Patients with chronic gastrointestinal dysfunction with obvious digestive and absorption disorders and other endocrine diseases, such as hyperthyroidism, hypercortisolism, acromegaly, etc.; 7. Patients with medical conditions that may be aggravated by flatulence (such as Roemheld syndrome, severe hernias, ileus, postoperative intestinal surgery, and intestinal ulcers); 8. serious heart disease, myocardial infarction, unstable angina pectoris and chronic cardiac insufficiency (NYHA class III and IV), acute cardiac insufficiency, six months after PCI or recent heart surgery plan; 9. Poor blood pressure control (SBP >= 160mmHg or DBP >= 100mmHg) of subjects (taking or not taking antihypertensive drugs); 10. patients with liver disease, ALT or AST > 2 x ULN or TBil > 2 x ULN, and confirmed by reexamination within 1 week; 11. renal function impairment (Cr > 1 x ULN or Ccr < 60ml/min), and confirmed by reexamination within 1 week; 12. Combined use of drugs that affect glucose metabolism, such as glucocorticoids; 13. Use of Chinese herbal medicine with the effect of regulating blood sugar within three months; 14. Persons with serious medical conditions who are at risk of dying during the treatment and follow-up periods; 15. Persons with mental or neurological disorders and unable to express their wishes correctly; 16. Alcoholics and substance abusers and addicts; 17. Women of childbearing age who are pregnant, breastfeeding, have a positive pregnancy intention or pregnancy test (urine HCG or blood HCG) and who should not take effective contraceptive measures during the test (effective contraceptive measures include sterilization, iUDS, oral contraceptives or diaphragms as required by local law); 18. Participated in clinical trials of other drugs or medical devices in recent three months; 19. Patients with other diseases that the investigator considers will be unable to evaluate efficacy or 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);body weight; | — |
Countries
China
Contacts
Public ContactXiaochun Liang
Peking Union Medical College Hospital
Outcome results
None listed