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

Sun Yat-sen University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: CSII, Sitagliptin; Drug: CSII; Drug: CSII, Metformin, Pioglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT01471808

13560475186

Details and patient eligibility

About

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.

Enrollment: 264 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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 from21～35kg/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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 3 patient groups

CSII

Active Comparator group

Description:

continuous subcutaneous insulin infusion

Treatment:

Drug: CSII

Metformin & Pioglitazone

Active Comparator group

Description:

CSII combined with metformin and pioglitazone

Treatment:

Drug: CSII, Metformin, Pioglitazone

Sitagliptin

Active Comparator group

Description:

CSII combined with sitagliptin 100mg/d

Treatment:

Drug: CSII, Sitagliptin