A multicenter clinical study for Xiaoke formula based on PTP1B inhibition in the treatment of refractory type 2 diabetes mellitus

Not Applicable

• Conditions: Type 2 Diabetes

• Registration Number: ITMCTR1900002706
• Lead Sponsor: Yueyang Hospital of integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
glycosylated hemoglobin;C peptide;blood glucose;

Secondary Outcome Measures

Name	Time	Method
liver function;routine blood test;Urine routine;renal function;