Effects of Different Early Intensive Therapies on Long-term β-cell Function

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.metformin and pioglitazone combined with CSII; 3. sitagliptin combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Metformin; Pioglitazone; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• newly diagnosed type 2 diabetes

• fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L

• body mass index (BMI) ranging from20～35kg/m2

• Antihyperglycaemic and antihyperlipidemic medication-naive patients

Exclusion Criteria:

• 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