Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients

Evaluation of the Effects of Oral Anti-Hyperglycemic Agents, Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion on Glycemic Control, B-Cell Function and the Remission Rate in Newly-Diagnosed Type 2 Diabetic Patients

The purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections, 3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.

ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects responsible for the development of hyperglycemia. With continuous presence of insulin resistance, progressive loss of ß-cell function is the crucial defect. Hyperglycemia has deleterious effect on β-cell function, which is partially reversible by adequate glycemic control. In newly diagnosed type 2 diabetic patients with severe hyperglycemia, 2 weeks continuous subcutaneous insulin infusion (CSII) can induce adequate glycemic control with improvement of β-cell function. Nearly half of the patients can maintain euglycemia longer than 12 months by transient CSII. The improvement of β-cell function, especially the restoration of the first-phase insulin response is related to sustained euglycemia in the newly diagnosed type 2 diabetic patients. But it is unclear whether any other interventions (such as oral hypoglycemic agents and multiple daily injections) inducing optimal glycemic control in a short period of time can have the same effect. As a multicenter, open-label, randomized, parallel-group study will be needed to further prove and clarify the findings.

Inclusion Criteria:

1. informed consents be given before treatment
2. the newly-diagnosed type 2 diabetic patients
3. fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
4. age ranging from 25～70 years old
5. body mass index (BMI) ranging from20～35kg/m2
6. never be treated with any anti-hyperglycemic agents or anti-hyperlipidemic agents

Exclusion Criteria:

1. having any severe acute or chronic complications
2. renal dysfunction, blood creatinine≥150µmol/L
3. blood aminotransferase level rising up(more than 2 times of the normal level)
4. any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
5. serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
6. chronic or acute pancreatic disease
7. severe systematic diseases or malignant tumor
8. allergic to the drugs using in the trial
9. any factors interfering the result
10. female patients incline to be pregnant
11. being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
12. poor compliance