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

Phase 4

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: CSII; Drug: Liraglutide

• Registration Number: NCT01790308
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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 Timeline

• Status Verified: 2013-02
• Study Start: 2013-02
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-11
• Last Update Submitted: 2013-02-11
• Study First Posted: 2013-02-13
• Last Update Posted: 2013-02-13
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide	CSII	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
CSII	CSII	continuous subcutaneous insulin infusion for 2-4 weeks
Liraglutide	Liraglutide	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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