Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus-type-2
Started Feb 2013
Longer than P75 for phase_4 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 6, 2013
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 13, 2013
February 1, 2013
1.8 years
February 6, 2013
February 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
the percentage of the patients who maintain glucose control 1 year after short intensive therapy
1 year
Secondary Outcomes (2)
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
Study Arms (2)
CSII
ACTIVE COMPARATORcontinuous subcutaneous insulin infusion for 2-4 weeks
Liraglutide
ACTIVE COMPARATORcontinuous 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
Interventions
CSII for 2\~4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanbing Li, MD
Ministry of Education
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University
Study Record Dates
First Submitted
February 6, 2013
First Posted
February 13, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
February 13, 2013
Record last verified: 2013-02