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

February 11, 2013 updated by: Yanbing Li, Sun Yat-sen University

Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission 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) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yanbing Li, MD, Ministry of Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 6, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13450149260

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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