Type 2 Diabetes MellitusPhase 4NCT00948324
Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes
A Phase 4 study testing CSII,ALA,MET,RSG in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen University.
Trial summary
The purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.continuous subcutaneous insulin infusion combined with rosiglitazone 3.continuous subcutaneous insulin infusion combined with metformin,4.continuous subcutaneous insulin… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- CSII,ALA,MET,RSG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Dec 2021
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed type 2 diabetes,
Who cannot join
- received previous antihyperglycaemic therapy
About this study
The purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.continuous subcutaneous insulin infusion combined with rosiglitazone 3.continuous subcutaneous insulin infusion combined with metformin,4.continuous subcutaneous insulin infusion combined with α- thioctic acid daily injections,) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- CSII,ALA,MET,RSG
- Keywords
- ype 2 diabetes mellitus, continuous subcutaneous insulin infusion,, α-lipoic acid ,rosiglitazone ,metformin，therapy
- 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.
CSII,ALA,MET,RSGDrug
CSII along.ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. RSG:CSII combined with three months rosiglitazoneor 4mg QD. MET:CSII combined with metformin 500mg BID-TID.
| Study group | Role | What they receive |
|---|---|---|
| CSII | Active comparator | CSII: Patients in continuous subcutaneous insulin infusion group received insulin analogue with an insulin pump along. Receives: Drug: CSII,ALA,MET,RSG |
| ALA | Active comparator | ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. Receives: Drug: CSII,ALA,MET,RSG |
| RSG | Active comparator | RSG:CSII combined with three months rosiglitazoneor 4mg QD. Receives: Drug: CSII,ALA,MET,RSG |
| MET | Active comparator | MET:CSII combined with metformin 500mg BID-TID. Receives: Drug: CSII,ALA,MET,RSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
beta cell function;fast blood glucose;
Measured: 2011/05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 400 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
- Li Yan Bing, MD, Principal investigator, Ministry of Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948324
- Sponsor's protocol ID
- 87755766
- Status last verified
- Oct 2017
- First submitted
- 28 Jul 2009
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu L, Ke W, Wan X, Zhang P, Cao X, Deng W, Li Y. Insulin requirement profiles of short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes and its association with long-term glycemic remission. Diabetes Res Clin Pract. 2015 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21.
PubMed 25765670
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00948324
- Acronym / sponsor ID
- 87755766
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- ype 2 diabetes mellitus, continuous subcutaneous insulin infusion,, α-lipoic acid ,rosiglitazone ,metformin，therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Jul 2009 (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 different interventions (1.continuous subcutaneous insulin infusion,2.continuous subcutaneous insulin infusion combined with rosiglitazone 3.continuous subcutaneous insulin infusion combined with metformin,4.continuous subcutaneous insulin infusion combined with α- thioctic acid daily injections,) on glycemic control, B-cell function and the remission rate 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
- 4
| Arm | Type | Receives |
|---|---|---|
| CSII | Active comparator | Drug: CSII,ALA,MET,RSGCSII: Patients in continuous subcutaneous insulin infusion group received insulin analogue with an insulin pump along. |
| ALA | Active comparator | Drug: CSII,ALA,MET,RSGALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. |
| RSG | Active comparator | Drug: CSII,ALA,MET,RSGRSG:CSII combined with three months rosiglitazoneor 4mg QD. |
| MET | Active comparator | Drug: CSII,ALA,MET,RSGMET:CSII combined with metformin 500mg BID-TID. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- newly diagnosed type 2 diabetes,
Key exclusion criteria (1 listed)
- received previous antihyperglycaemic therapy
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 |
|---|---|---|
| CSII,ALA,MET,RSGCSII along.ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. RSG:CSII combined with three months rosiglitazoneor 4mg QD. MET:CSII combined with metformin 500mg BID-TID. | Drug | ALA, CSII, MET, RSG |
Primary outcome
beta cell function;fast blood glucose;
Time frame: 2011/05
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Derived from this study: PubMed 25765670Liu L, Ke W, Wan X, Zhang P, Cao X, Deng W, Li Y. Insulin requirement profiles of short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes and its association with long-term glycemic remission. Diabetes Res Clin Pract. 2015 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21.
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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.
Li Yan Bing, MD principal investigator
Ministry of Education
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CSII,ALA,MET,RSG in people with Type 2 Diabetes Mellitus, 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 3 Oct 2017. 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?
beta cell function;fast blood glucose; (time frame: 2011/05). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948324, which also lists 1 linked publication.
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 3 Oct 2017.