Type 2 diabetes mellitus
Conditions
Interventions
Intensive insulin therapy group:Insulin
Oral drug group:Metformin and/or Glimepiride
Sponsors
Renmin Hospital of Three Gorges University
Eligibility
Sex/Gender
All
Age
21 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. New diagnosis of type 2 diabetes mellitus (WHO, 1999 criteria) without drug treatment; 2. Aged 21~65 years old, no limit for men and women; 3. HbA1c:6.5%~8.5%; fasting blood glucose; <10.0mmol/L; OGTT test; 2 hours blood sugar; <16.0mmol/L; 4. 20kg/m2 = BMI = 35kg/m2, the weight in an 3 month before the screening, the degree of variation=10%; 5. Female patients who have died prior to screening, or undergoing birth control, or using contraceptives or other methods of contraception, are committed to contraception during the course of the study; 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Diabetic ketosis or ketoacidosis, diabetes lactic acidosis and other acute complications of diabetes or severe chronic complications of diabetes; 2. Congestive heart failure (1928 grade NYHA, grade III and grade IV); 3. Severe osteoporosis or previous pathological fracture history, or is currently taking bisphosphonate drugs for osteoporosis; 4. Severe gastrointestinal lesions; 5. Other serious concomitant diseases; 6. During the trail, AST, ALT higher than 2.5 times the upper limit of normal and / or serum creatinine of more than 133 mol/L (1.5mg/dL),or active liver disease and jaundice occurred in the study; 7. GAD65 positive; type 1 diabetes mellitus or specific diabetes mellitus; 8. Use of weight loss, gastrointestinal function, long-term or repeated use of systemic corticosteroids, immunosuppressive treatment or other experimental drugs; 1 weeks before the experimental period to take hypoglycemic traditional Chinese medicine. 9. Have a history of pancreatitis; 10. Serum triglycerides than 5.0mmol/L; 11. Pregnancy or lactation; 12.Participated in any other clinical research program within 3 months; 13. Have serious allergies associated with drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Describe the general characteristics of patients in the experimental and control groups;Serum IL-18 levels were measured before and after treatment in each group;Serum RBP-4 levels were measured before and after treatment in each group;Fasting Blood Glucose levels were measured before and after treatment in each group;HbA1C levels were measured before and after treatment in each group;HOMA-IR levels were measured before and after treatment in each group; | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI levels were measured before and after treatment in each group;Hypoglycemia incidence;Total cholesterol levels were measured before and after treatment in each group;LDL-C levels were measured before and after treatment in each group;triglyceride levels were measured before and after treatment in each group; | — |
Countries
China
Contacts
Public ContactXiulan Zou
Renmin Hospital of Three Gorges University
Outcome results
None listed