Type 2 Diabetes Mellitus
Conditions
Keywords
type 2 diabetes mellitus, therapy, sulfonylureas, metformin, insulin
Brief summary
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.
Detailed description
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.
Interventions
DRUGHuman Insulin (Novolin-R, Novo Nordisk)
OTHERPre-meal
DRUGNovolin-R
DRUGHuman Insulin NPH (Novolin-N, Novo Nordisk)
DRUGGliclazide (Diamicron, Servier)
DRUGDiamicron and Glucophage
Sponsors
Ministry of Education, China
Guangdong Science and Technology Bureau, China
Hoffmann-La Roche
Novo Nordisk A/S
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| glycemic control, the improvement of β-cell l function and the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients | Oct. 2007 |
Secondary
| Measure | Time frame |
|---|---|
| the effects of different interventions (oral anti-hyperglycemic agents, multiple daily injections and continuous subcutaneous insulin infusion) on glycemic control, β-cell function and the remission rate in newly-diagnosed type 2 diabetic patients | Oct. 2007 |
Countries
China
Outcome results
None listed