Type II diabetes mellitus
Conditions
Interventions
Group 1:Xiaoke Wan
Group 2:Glibenclamide
Group 3:Metformin and Xiaoke Wan
Group 4:Metformin and Glibenclamide
Sponsors
PKU People's Hospital
Eligibility
Sex/Gender
All
Age
21 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participant attend voluntarily and sign the informed consent form; 2. Patients with type II diabetes mellitus; 3. Patients are diagnosed as Qi-Yin Deficiency Syndrome; 4. Age: 21-70 years; 5. Naive patients: without medication history of hypoglycemic drug and obesity and the BMI is between 18kg/m2-28 kg/m2 (not included); 6. Patients taking metformin: receive metformin >750 mg/day 3 months at least before screening and the BMI is between 18kg/m2-35 kg/m2 (not included); 7. Stable body weight (fluctuation is less than 10%); 8. Bad control of blood sugar. The fasting blood sugar is more than 126 mg/dl(7.0mmol/L) and HbA1c >7.0% (first screen) and fasting blood sugar is more than 126 mg/dl (7.0mmol/L)(after lead-in period); 9. meet the above standard after lead-in period of 4 weeks (HbA1c is not considered).
Exclusion criteria
Exclusion criteria: 1. Research stuff and their relatives; 2. Employed personnel in the applicant company; 3. The patients have participated in this or other research with medication of sulfonylurea drug; 4. The patients have participated in researches of intervention therapy of internal meidicine, sugery or pharmacology 30 days before screening; 5. Pregnant or breast-feeding women at reproductive age; 6. The pasting blood sugar >13mmol/L or HbA1c >11%; 7. Three onsets of serious hypoglycemia 6 months before screening; 8. Allergic to sulfonylurea drug; 9. Contraindications of metformin and sulfonylurea drug; 10. Insulin therapy of more than one week three months before screening; 11. History of various heart disease including myocardial infarction, arrhythmia, unstable angina and heart failure (Grade III or IV); 12. History of kidney transplantation or dialysis therapy or blood creatine concentration is higher than upper normal limit; 13. With conspicuous clinical symptoms or signs of hepatic disease, acute or chronic hepatitis or ALT/AST is 2.5 times more than upper normal limit; 14. Complicated with hemoglobinpathy or chronic anemia; 15. Complicated with active proliferative renal disease; 16. Medication of TZD, insulinotropic agents, a-glucosidase inhibitors or glucocorticoid; 17. Malignant tumor is active or not treated or clinical relief shorter than five years except basal cell carcinoma, squamous cell carcinoma, cervical cancer and prostate cancer; 18. History of organ transplantation; 19. Abuse of drug or alcohol; 20. Other conditions are not proper for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Control rate;Failure rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of complications;Laboratory index;The relation between the genetic and metabolic change and efficacy and safety;Evaluation of curative effects on symptoms; | — |
Countries
China
Contacts
Public ContactLinong Ji
Outcome results
None listed