Diabetes Mellitus, Type 2Phase 4NCT01471808
Effects of Different Early Intensive Therapies on Long-term β-cell Function
A Phase 4 study testing CSII, CSII, Metformin, Pioglitazone and CSII, Sitagliptin 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 different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CSII, CSII, Metformin, Pioglitazone and CSII, Sitagliptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Dec 2018
- 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 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 7.0～16.7 mmol/L
- body mass index (BMI) ranging from21～35kg/m2
- Antihyperglycaemic and antihyperlipidemic medication-naive patients
Who cannot join
- having any severe acute or chronic diabetic complications
- renal dysfunction, blood creatinine≥150µmol/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 systematic diseases or malignant tumor
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- female patients incline to be pregnant
- being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
- poor compliance
About this study
Official title: Effects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients
The purpose of this study is to investigate and evaluate the effects of different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin 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, CSII, Metformin, Pioglitazone, CSII, Sitagliptin
- 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
CSII, Metformin, PioglitazoneDrug
CSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.
CSII, SitagliptinDrug
CSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months
| Study group | Role | What they receive |
|---|---|---|
| CSII | Active comparator | continuous subcutaneous insulin infusion Receives: Drug: CSII |
| Metformin & Pioglitazone | Active comparator | CSII combined with metformin and pioglitazone Receives: Drug: CSII, Metformin, Pioglitazone |
| Sitagliptin | Active comparator | CSII combined with sitagliptin 100mg/d Receives: Drug: CSII, Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportions of 1 year remission of type 2 diabetes
the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients
Measured: 1 years
Secondary outcomes (1)
the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2018
- Study completionDec 2018
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 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
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Shenzhen Hospital, First People's Hospital of Foshan
- Responsible party
- Principal investigator, Yanbing Li, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yanbin Li, MD, Principal investigator, Ministry of Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471808
- Sponsor's protocol ID
- 13560475186
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2011
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01471808
- Acronym / sponsor ID
- 13560475186
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Shenzhen Hospital, First People's Hospital of Foshan
- Study start
- Oct 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 Nov 2011 (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 oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin 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
- 3
| Arm | Type | Receives |
|---|---|---|
| CSII | Active comparator | Drug: CSIIcontinuous subcutaneous insulin infusion |
| Metformin & Pioglitazone | Active comparator | Drug: CSII, Metformin, PioglitazoneCSII combined with metformin and pioglitazone |
| Sitagliptin | Active comparator | Drug: CSII, SitagliptinCSII combined with sitagliptin 100mg/d |
Who may qualify
- Ages
- 25 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 7.0～16.7 mmol/L
- body mass index (BMI) ranging from21～35kg/m2
- Antihyperglycaemic and antihyperlipidemic medication-naive patients
Key exclusion criteria (9 listed)
- having any severe acute or chronic diabetic complications
- renal dysfunction, blood creatinine≥150µmol/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 |
| CSII, Metformin, PioglitazoneCSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months. | Drug | Metformin & Pioglitazone |
| CSII, SitagliptinCSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months | Drug | Sitagliptin |
Primary outcome
proportions of 1 year remission of type 2 diabetes
Time frame: 1 years
the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients
1 secondary outcome
the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- 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.
- Individual participant dataSharing planned: No
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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.
Yanbin Li, MD principal investigator
Ministry of Education
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CSII, CSII, Metformin, Pioglitazone and CSII, Sitagliptin 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: finished, as of the sponsor's last update on 24 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportions of 1 year remission of type 2 diabetes (time frame: 1 years). 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 NCT01471808, 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 24 Sep 2025.