Status:
COMPLETED
Effects of Different Early Intensive Therapies on Long-term β-cell Function
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
25-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate and evaluate the effects of different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2...
Eligibility Criteria
Inclusion
- newly diagnosed type 2 diabetes
- fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
- body mass index (BMI) ranging from21～35kg/m2
- Antihyperglycaemic and antihyperlipidemic medication-naive patients
Exclusion
- having any severe acute or chronic diabetic complications
- renal dysfunction, blood creatinine≥150µmol/L
- blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT)
- • Any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months
- chronic or acute pancreatic disease
- severe systematic diseases or malignant tumor
- female patients incline to be pregnant
- being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
- poor compliance
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT01471808
Start Date
October 1 2011
End Date
December 1 2018
Last Update
September 24 2025
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