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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function in Newly-diagnosed Type 2 Diabetic Patients

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: CSII
* Drug: Liraglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CSII<br>continuous subcutaneous insulin infusion for 2-4 weeks | Drug: CSII<br>* continuous subcutaneous insulin infusion for 2 4 weeks<br>|
| Active Comparator: Liraglutide<br>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 | Drug: CSII<br>* continuous subcutaneous insulin infusion for 2 4 weeks<br>Drug: Liraglutide<br>* CSII for 2 4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of the patients who maintain glucose control 1 year after short intensive therapy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients |  | 1 year | 
| the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients |  | 1 year |