Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: CSII; Drug: Liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT01790308

13450149260

Details and patient eligibility

About

The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

Full description

The purpose of this study is to investigate and evaluate the effects of liraglutide combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.liraglutide combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed type 2 diabetes
• fasting blood glucose (FBG) level ranging from 7.0-16.7mmol/L
• body mass index (BMI) ranging from 21-35kg/m2
• antihypercaemic and antihyperlipidemic medication-naive patients

Exclusion criteria

• having any severe acute or chronic diabetic complications
• renal dysfunction, blood creatinine>150umol/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 systemic diseases or malignant tumor
• female patients incline to be pregnant
• being treated with corticosteriod, 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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100 participants in 2 patient groups

CSII

Active Comparator group

Description:

continuous subcutaneous insulin infusion for 2-4 weeks

Treatment:

Drug: CSII

Liraglutide

Active Comparator group

Description:

continuous subcutaneous insulin infusion for 2-4 weeks combined with combined with Liraglutide 0.6mg/d for 2-4 weeks and 1.2mg/d for next 9 weeks

Treatment:

Drug: Liraglutide

Drug: CSII