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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

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.

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CSII

continuous subcutaneous insulin infusion for 2-4 weeks

Group Type ACTIVE_COMPARATOR

CSII

Intervention Type DRUG

continuous subcutaneous insulin infusion for 2\~4 weeks

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

Group Type ACTIVE_COMPARATOR

CSII

Intervention Type DRUG

continuous subcutaneous insulin infusion for 2\~4 weeks

Liraglutide

Intervention Type DRUG

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

Interventions

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CSII

continuous subcutaneous insulin infusion for 2\~4 weeks

Intervention Type DRUG

Liraglutide

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

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No