Status:
COMPLETED
Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Ministry of Education, China
Guangdong Science and Technology Bureau, China
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-70 years
Phase:
NA
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...
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, progressi...
Eligibility Criteria
Inclusion
- informed consents be given before treatment
- the newly-diagnosed type 2 diabetic patients
- fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
- age ranging from 25～70 years old
- body mass index (BMI) ranging from20～35kg/m2
- never be treated with any anti-hyperglycemic agents or anti-hyperlipidemic agents
Exclusion
- having any severe acute or chronic complications
- renal dysfunction, blood creatinine≥150µmol/L
- blood aminotransferase level rising up(more than 2 times of the normal level)
- any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
- serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
- chronic or acute pancreatic disease
- severe systematic diseases or malignant tumor
- allergic to the drugs using in the trial
- any factors interfering the result
- female patients incline to be pregnant
- being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
- poor compliance
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT00147836
Start Date
September 1 2004
End Date
October 1 2007
Last Update
April 1 2008
Active Locations (1)
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1
the first Affiliated Hospital of Sun Yat-Sen university
Guangzhou, Guangdong, China, 510080