T2DMPhase 4NCT03563794
Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
A Phase 4 study testing CSII+Vildagliptin and CSII(insulin Lispro) in people with T2DM, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- T2DM
- What is being tested?
- CSII+Vildagliptin and CSII(insulin Lispro)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2018to 10 Dec 2019
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2DM
- 30≤ age≤70 years old
- BMI 18.0-28.0 Kg/m2
- HbA1c ≥8.5%
- Negtive GAD、ICA、IAA
- Patients do not use antihyperglycemia drugs
- Patients use antihyperglycemia drugs for ≥8 weeks(exclusion of DPP-4 inhibitors and GLP-1 receptor agonist)
Who cannot join
- T1DM,GDM
- Congestive heart failure (New York Heart Association Functional Classification III-IV)
- ALT or AST> 2 times above normal,GFR <50ml/min
- Severe infection in the previous 3 months
- Severely acute or chronic diabetic complications
- Patients who were taking medications,known to affect glycaemic control, such as glucocorticoids(aside from antidiabetic medications)
Show all 9Show fewer
- History of pancreatitis
- Trauma or patients operating at a scheduled time
- Any mental health condition
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first afilliated hospital of Xiamen university
Xiamen, Fujian, 361003
Xue-jun Li, MD,PHD, 13860451316, lixuejue99@yahoo.com.cn
Xue-jun Li, MD,PhD
About this study
The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes
- Conditions
- T2DM
- Being tested
- CSII+Vildagliptin, CSII(insulin Lispro)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSII+VildagliptinDrug
Vildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.
CSII(insulin Lispro)Drug
T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.
| Study group | Role | What they receive |
|---|---|---|
| CSII(insulin Lispro)+Vildagliptin | Experimental | Vildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days. Receives: Drug: CSII+Vildagliptin |
| CSII(insulin Lispro) | Active comparator | T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days. Receives: Drug: CSII(insulin Lispro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose
changes from baseline in FPG and 2hPBG
Measured: 7 days
Secondary outcomes (1)
hypoglycemia
frequancy of hypoglycemia
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start10 Jun 2018 (estimated)
- Primary completion10 Jun 2019 (estimated)
- Study completion10 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DMStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563794
- Sponsor's protocol ID
- CSII vs CSII+DPP-4 inhibitor
- Status last verified
- Jun 2018
- First submitted
- 10 Jun 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03563794
- Acronym / sponsor ID
- CSII vs CSII+DPP-4 inhibitor
- Conditions
- T2DM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 10 Jun 2018 (estimated)
- Primary completion
- 10 Jun 2019 (estimated)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 20 Jun 2018 (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.
The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSII(insulin Lispro)+Vildagliptin | Experimental | Drug: CSII+VildagliptinVildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days. |
| CSII(insulin Lispro) | Active comparator | Drug: CSII(insulin Lispro)T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- T2DM
- 30≤ age≤70 years old
- BMI 18.0-28.0 Kg/m2
- HbA1c ≥8.5%
- Negtive GAD、ICA、IAA
Key exclusion criteria (9 listed)
- T1DM,GDM
- Congestive heart failure (New York Heart Association Functional Classification III-IV)
- ALT or AST> 2 times above normal,GFR <50ml/min
- Severe infection in the previous 3 months
- Severely acute or chronic diabetic complications
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+VildagliptinVildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days. | Drug | CSII(insulin Lispro)+Vildagliptin |
| CSII(insulin Lispro)T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days. | Drug | CSII(insulin Lispro) |
Primary outcome
blood glucose
Time frame: 7 days
changes from baseline in FPG and 2hPBG
1 secondary outcome
hypoglycemia
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Related trials for T2DM
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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.
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+Vildagliptin and CSII(insulin Lispro) in people with T2DM, run by The First Affiliated Hospital of Xiamen University 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 7 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 20 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiulin Shi, MD (13959284763, shixiulin2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose (time frame: 7 days). 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 20 Jun 2018.