Back to resultsEffect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
CSII
Liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CSII
Liraglutide
Arm Description
continuous subcutaneous insulin infusion for 2-4 weeks
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
Outcomes
Primary Outcome Measures
the percentage of the patients who maintain glucose control 1 year after short intensive therapy
Secondary Outcome Measures
the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients
the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients
Full Information
NCT ID
NCT01790308
First Posted
February 6, 2013
Last Updated
February 11, 2013
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01790308
Brief Title
Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function
Official Title
Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function in Newly-diagnosed Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CSII
Arm Type
Active Comparator
Arm Description
continuous subcutaneous insulin infusion for 2-4 weeks
Arm Title
Liraglutide
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CSII
Intervention Description
continuous subcutaneous insulin infusion for 2~4 weeks
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
CSII for 2~4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 months
Primary Outcome Measure Information:
Title
the percentage of the patients who maintain glucose control 1 year after short intensive therapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients
Time Frame
1 year
Title
the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanbing Li, MD
Organizational Affiliation
Ministry of Education
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function
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