Diabetes type2Phase 4NCT03958591
Impact of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification
A Phase 4 study testing CSII and thereafter combination therapy, followed up with wearable devices, CSII and thereafter combination therapy and Basal insulin treatment without wearables in people with Diabetes type2, run by Yanbing Li at 1 site in China.
Trial summary
Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes type2
- What is being tested?
- CSII and thereafter combination therapy, followed up with wearable devices, CSII and thereafter combination therapy and Basal insulin treatment without wearables
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2019to 31 May 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1~15 years;
- With two or more oral hypoglycemic drugs, or basal insulin and 1-2 oral hypglycemic agents, used for at least 3 months;
- HbA1c of 7.5 to 13% and fasting C-peptide > 0.4 nmol/L;
- Age of 18 to 70 years;
- BMI of 20 to 35 kg/m²；
- Capable of and willing to follow doctors' instructions to:
- Self-monitor blood glucose according to the protocol;
- Follow the protocol and have regular visits as required; ③ Record and maintain the research diary, as required by the protocol; ④ Keep contact with the investigators and receive phone calls during the study.
Who cannot join
- Type 1 diabetes or specific types of diabetes;
- Those who have received premixed insulin therapy and/or basal - meal insulin and/or basal insulin-oral hypoglycemic agents treatment accumulation for 7 days or more, and those who have received CSII therapy in the last one year, and those who have received GLP-1 analogue within 3 months before screening;
- Those who have acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
- Those who have severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria, and glomerular filtration rate less than 45 ml/min, uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy);
- Those with ALT >2.5 times of the upper limit of normal (ULN), bilirubin > 1.5 times of ULN；
- Those with known macrovascular disease: Patients with acute cerebrovascular accident, acute coronary syndrome, unstable angina, peripheral artery disease who have received vascular intervention or amputation in the 12 months before enrollment; Or chronic cardiac dysfunction with cardiac function grade III or above;
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- Those with poor blood pressure control (systolic blood pressure≥160mmHg and/or sitting diastolic blood pressure ≥110mmHg) and inability to control under 160/110mmhg within 1 week;
- Serious systemic disease or malignant tumor, chronic diarrhea, etc；
- Those with drugs that may affect blood glucose for a cumulative time of more than 1 week within 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ < 25mg/d, indapamide < 1.5mg/d) and physiologic dose of thyroid hormone for replacement therapy are not included；
- Any factors that may affect the participation of the subject in the study or the evaluation of the results；
- Pregnancy or planned pregnancy, lactation subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Short-term Intensive De-escalation Therapeutic Strategy on Long-term Regimen Simplification in Poorly Controlled Type 2 Diabetes: a National Multicenter, Prospective, Randomized Trial
Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. The investigators design this study and presume that using vildagliptin and metformin in combination with basal insulin as sequential treatment after intensive insulin therapy, might better modulate the dual islet hormone dysfunction than traditionally stepwise upgrading therapy pattern in patients with poorly controlled T2DM, and thus lead to a glucose normalization, β-cell function improvement and therapy simplification.
Read the detailed description
This is a multicenter, randomized, controlled, open-label, clinical superiority trial. The participants will be recruited from 10 centers in China. The enrolled participants will be randomly assigned into 3 groups.
Group CIW (CSII with wearables)：Continuous subcutaneous insulin infusion (CSII) will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended. The participants are wearing wearables.
Group CI (CSII without wearbles): CSII will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended.
Group BI (Basal insulin treatment): The participants will be applied the combination therapy of basal insulin, vildagliptin and metformin for the entire 12 weeks and then insulin will be suspended.
Participants will then receive combination therapy of metformin and vildagliptin. If the participants cannot tolerate metformin, then acarbose (50-100mg tid) or SGLT2 inhibitor can be instead used. If glucose is not well controlled, sulfonylureas or glinides can be added as a rescue treatment.
- Conditions
- Diabetes type2
- Being tested
- CSII and thereafter combination therapy, followed up with wearable devices, CSII and thereafter combination therapy, Basal insulin treatment without wearables
- Keywords
- Intensive therapy, treatment de-escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSII and thereafter combination therapy, followed up with wearable devicesDrug
Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices will be used during the follow-up.
CSII and thereafter combination therapyDrug
Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin.
Basal insulin treatment without wearablesDrug
The participants will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CSII with wearables | Experimental | Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. Wearable devices will be used. Receives: Drug: CSII and thereafter combination therapy, followed up with wearable devices |
| CSII without wearbles | Experimental | Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. Receives: Drug: CSII and thereafter combination therapy |
| Basal insulin group | Active comparator | The combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks and thereafter the oral hypoglycemic therapies will be applied. Receives: Drug: Basal insulin treatment without wearables |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportions of treatment de-escalation
the proportions of patients who can use only combination of two oral hypoglycemic agents
Measured: From enrollment to the end of treatment at week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start22 Jul 2019
- Primary completion1 Sep 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type2Studies of the same condition, open and under way.
- 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
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanbing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanbing Li, Sun Yat-sen University
- Investigators
- Yanbing Li, Dr, Principal investigator, FAH-SYSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958591
- Sponsor's protocol ID
- 2018YFC1314103
- Status last verified
- Sep 2026
- First submitted
- 20 May 2019
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Short-term Intensive De-escalation Therapeutic Strategy on Long-term Regimen Simplification in Poorly Controlled Type 2 Diabetes: a National Multicenter, Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT03958591
- Acronym / sponsor ID
- 2018YFC1314103
- Conditions
- Diabetes type2
- Keywords
- Intensive therapy, treatment de-escalation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Yanbing LiUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 22 May 2019 (actual)
- 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.
Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. The investigators design this study and presume that using vildagliptin and metformin in combination with basal insulin as sequential treatment after intensive insulin therapy, might better modulate the dual islet hormone dysfunction than traditionally stepwise upgrading therapy pattern in patients with poorly controlled T2DM, and thus lead to a glucose normalization, β-cell function improvement and therapy simplification.
Detailed description
This is a multicenter, randomized, controlled, open-label, clinical superiority trial. The participants will be recruited from 10 centers in China. The enrolled participants will be randomly assigned into 3 groups.
Group CIW (CSII with wearables)：Continuous subcutaneous insulin infusion (CSII) will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended. The participants are wearing wearables.
Group CI (CSII without wearbles): CSII will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended.
Group BI (Basal insulin treatment): The participants will be applied the combination therapy of basal insulin, vildagliptin and metformin for the entire 12 weeks and then insulin will be suspended.
Participants will then receive combination therapy of metformin and vildagliptin. If the participants cannot tolerate metformin, then acarbose (50-100mg tid) or SGLT2 inhibitor can be instead used. If glucose is not well controlled, sulfonylureas or glinides can be added as a rescue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CSII with wearables | Experimental | Drug: CSII and thereafter combination therapy, followed up with wearable devicesShort-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. Wearable devices will be used. |
| CSII without wearbles | Experimental | Drug: CSII and thereafter combination therapyShort-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. |
| Basal insulin group | Active comparator | Drug: Basal insulin treatment without wearablesThe combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks and thereafter the oral hypoglycemic therapies will be applied. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1~15 years;
- With two or more oral hypoglycemic drugs, or basal insulin and 1-2 oral hypglycemic agents, used for at least 3 months;
- HbA1c of 7.5 to 13% and fasting C-peptide > 0.4 nmol/L;
- Age of 18 to 70 years;
- BMI of 20 to 35 kg/m²；
Key exclusion criteria (11 listed)
- Type 1 diabetes or specific types of diabetes;
- Those who have received premixed insulin therapy and/or basal - meal insulin and/or basal insulin-oral hypoglycemic agents treatment accumulation for 7 days or more, and those who have received CSII therapy in the last one year, and those who have received GLP-1 analogue within 3 months before screening;
- Those who have acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
- Those who have severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria, and glomerular filtration rate less than 45 ml/min, uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy);
- Those with ALT >2.5 times of the upper limit of normal (ULN), bilirubin > 1.5 times of ULN；
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 and thereafter combination therapy, followed up with wearable devicesShort-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices will be used during the follow-up. | Drug | CSII with wearables |
| CSII and thereafter combination therapyShort-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin. | Drug | CSII without wearbles |
| Basal insulin treatment without wearablesThe participants will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks. | Drug | Basal insulin group |
Primary outcome
the proportions of treatment de-escalation
Time frame: From enrollment to the end of treatment at week 36
the proportions of patients who can use only combination of two oral hypoglycemic agents
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 5 Nov 2026.
- 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.
Yanbing Li, Dr principal investigator
FAH-SYSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CSII and thereafter combination therapy, followed up with wearable devices, CSII and thereafter combination therapy and Basal insulin treatment without wearables in people with Diabetes type2, run by Yanbing Li at 1 site in China.
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 8 inclusion and 11 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the proportions of treatment de-escalation (time frame: From enrollment to the end of treatment at week 36). 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 5 Nov 2026.