Type 2 Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years male and female; 2. type 2 diabetes patients who meet the diagnostic criteria of Western medicine for diabetes; those who meet the syndrome of deficiency of both qi and Yin in traditional Chinese medicine; 3. those who use insulin (> 0.6 IU/kg) and metformin as the basic treatment, combined with one or two other hypoglycemic drugs, and the dosage is stable, no less than 4 weeks; 4. those who have poor blood glucose control: Blood FPG 7.5 to 10.0 mmol/l; HbA1c 7 to 10.0% (subject to the test value of each center); 5. the subject is informed and signs the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Gestational diabetes mellitus, type 1 diabetes mellitus and other special types of diabetes mellitus; 2. patients with acute complications of diabetes mellitus; 3. patients with serious cardiovascular and cerebrovascular diseases and serious primary diseases such as liver, kidney and hematopoietic system; 4. those who are allergic to the known ingredients of the study drug and whose constitution is allergic; 5. pregnant and lactating women and those who have recently had fertility plans; 6. those who have long-term alcohol, drug dependence and mental illness Patients with disease; 7. patients treated with traditional Chinese medicine or proprietary Chinese medicine with oral hypoglycemic purpose within one month before screening; 8. those who participated in or are participating in clinical trials of other drugs within one month before the screening period of this study; 9. researchers think that they are not suitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood glucose;glycosylated hemoglobin;C peptide; | — |
Secondary
| Measure | Time frame |
|---|---|
| routine blood test;Urine routine;liver function;renal function; | — |
Countries
China
Contacts
Yueyang Hospital of integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine