ITMCTR1900002706Not yet recruiting未知
A multicenter clinical study for Xiaoke formula based on PTP1B inhibition in the treatment of refractory type 2 diabetes mellitus
Yueyang Hospital of integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 18 to 75 (—)
- Sex
- All
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
- •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.
Investigators
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