- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01790308
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
|
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
|
continuous subcutaneous insulin infusion for 2~4 weeks
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
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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