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

Sun Yat-sen University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Diabetes Mellitus, Type 2

Interventions

CSIIDRUG

continuous subcutaneous insulin infusion for 2\~4 weeks

LiraglutideDRUG

CSII for 2\~4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 months

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

the percentage of the patients who maintain glucose control 1 year after short intensive therapy

Time frame: 1 year

Secondary Outcomes

the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients

Time frame: 1 year

the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients

Time frame: 1 year

Data from ClinicalTrials.gov

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