Type 2 Diabetes Mellitus
Conditions
Interventions
Experiment group:TangningTongluo capsule once 4, 3 times a day, after meals
placebo group:TangningTongluo capsule simulants, a 4, 3 times a day, after meals
Sponsors
The Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. In line with WHO 1999 type 2 diabetes diagnostic criteria; 2. newly diagnosed patients at the age of 30-75 with type 2 diabetes; 3. Course of disease within 12 months and did not take hypoglycemic drugs, or medication history 7.0% (Test results within 7 days before receiving the informed consent); 5. After the treatment of "diabetes diet control and exercise therapy" for 2 weeks, the patient's test results should be HbA1c 7.0 to 9.0% (detected by the Research Institute where they are), and 7.0 mmol/L=fasting venous plasma glucose=10 mmol/L or fasting venous plasma glucose <7.0mmol/L but 2 hours postprandial venous plasma glucose =11.1mmol/L; 6. BMI<45kg/m^2; 7. To sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Within the past month the patients suffering from diabetic ketosis,ketoacidosis, severe infection and traumaand major surgery; 2. The patients with hepatic dysfunction (AST / ALT> 2.5 times the upper limit of normal), pulmonary insufficiency, heart failure, acute myocardial infarction and other serious primary diseases; 3. Triglycerides (TG) = 5.7mmol/L; 4. Urinary protein (++) and above; 5. Male serum creatinine level >133umol/L; Female serum creatinine level> 124umol/L, or eGFR=60mL/min was calculated by using simplified MDRD formula; 6. Women in pregnancy, preparation for pregnancy or lactation; 7. The patients who are allergic to the ingredients in this drug; 8. Drug-dependent patients, or patients with mental disorders; 9. The patients who have participated in or are participating in other clinical trials within 3 months; 10. Researchers consider that the patients who are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of HbAlc compared with the baseline after 24weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| FPG;standard postprandial 2 hours plasma glucose;fasting insulin and c-peptide;insulin resistance index and insulin secretion index;The proportion of patients whose HbA1c is less than 7.0%;The proportion of patients whose HbA1c is less than 6.5% after 24 weeks of treatment;weight;BMI; | — |
Countries
China
Contacts
Public ContactShi Lixin
The Affiliated Hospital of Guizhou Medical University
Outcome results
None listed