Diabetes Mellitus, Type 2Phase 4NCT01790308
Effect of Liraglutide Combined With Short-term CSII on Long-term Glycemic Remission and β Cell Function
A Phase 4 study testing CSII and Liraglutide in people with Diabetes Mellitus, Type 2, run by Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CSII and Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- female patients incline to be pregnant
- being treated with corticosteriod, immunosuppressing drugs or cytotoxic drugs
- poor compliance
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CSII, Liraglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSIIDrug
continuous subcutaneous insulin infusion for 2~4 weeks
LiraglutideDrug
CSII for 2~4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 months
| Study group | Role | What they receive |
|---|---|---|
| CSII | Active comparator | continuous subcutaneous insulin infusion for 2-4 weeks Receives: Drug: CSII |
| Liraglutide | Active comparator | 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 Receives: Drug: CSII; Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of the patients who maintain glucose control 1 year after short intensive therapy
Measured: 1 year
Secondary outcomes (2)
the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients
Measured: 1 year
the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbing Li, Sun Yat-sen University
- Investigators
- Yanbing Li, MD, Principal investigator, Ministry of Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790308
- Sponsor's protocol ID
- 13450149260
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01790308
- Acronym / sponsor ID
- 13450149260
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSII | Active comparator | Drug: CSIIcontinuous subcutaneous insulin infusion for 2-4 weeks |
| Liraglutide | Active comparator | Drug: CSII, Drug: Liraglutidecontinuous 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSIIcontinuous subcutaneous insulin infusion for 2~4 weeks | Drug | CSII, Liraglutide |
| LiraglutideCSII for 2~4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 months | Drug | Liraglutide |
Primary outcome
the percentage of the patients who maintain glucose control 1 year after short intensive therapy
Time frame: 1 year
2 secondary outcomes
the acute insulin response reflected β-cell function of different interventions in newly-diagnosed type 2 diabetic patients
Time frame: 1 year
the remission rate differ from interventions in newly-diagnosed type 2 diabetic patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanbing Li, MD principal investigator
Ministry of Education
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CSII and Liraglutide in people with Diabetes Mellitus, Type 2, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of the patients who maintain glucose control 1 year after short intensive therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.