Diabetes Mellitus, Type 2Phase 4NCT03509324
Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes
A Phase 4 study testing Insulin LISPRO in people with Diabetes Mellitus, Type 2, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to investigate and evaluate the significance of intravenous glucose tolerance test in assessment of β-cell function improvement after short course of intensive insulin therapy, trying to illustrate the relationship between fasting plasma glucose and acute insulin release under different… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin LISPRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2015to 30 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- acute complication or severe comorbidities
Trial locations and contacts
1 site in 1 country.
China1 site
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Effectiveness and Determinants of Glucose Control, β-cell Function in Response to Short-term Intensive Insulin Pump Therapy in Different Duration of Type 2 Diabetes Mellitus.
The purpose of this study is to investigate and evaluate the significance of intravenous glucose tolerance test in assessment of β-cell function improvement after short course of intensive insulin therapy, trying to illustrate the relationship between fasting plasma glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic control.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin LISPRO
- 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.
Insulin LISPRODrug
Also called humalog
receive short-term insulin pump therapy by using insulin LISPRO, continue treatment for 7 more days when euglycemia achieved
| Study group | Role | What they receive |
|---|---|---|
| duration of disease | Other | different duration of disease receive insulin LISPRO Receives: Drug: Insulin LISPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting plasma glucose after insulin therapy
Measured: 10 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Mar 2015
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
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,PhD, Principal investigator, Ministry of Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509324
- Sponsor's protocol ID
- DMT20150410
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Determinants of Glucose Control, β-cell Function in Response to Short-term Intensive Insulin Pump Therapy in Different Duration of Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT03509324
- Acronym / sponsor ID
- DMT20150410
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 26 Apr 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 purpose of this study is to investigate and evaluate the significance of intravenous glucose tolerance test in assessment of β-cell function improvement after short course of intensive insulin therapy, trying to illustrate the relationship between fasting plasma glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| duration of disease | Other | Drug: Insulin LISPROdifferent duration of disease receive insulin LISPRO |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- acute complication or severe comorbidities
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 |
|---|---|---|
| Insulin LISPROAlso: humalogreceive short-term insulin pump therapy by using insulin LISPRO, continue treatment for 7 more days when euglycemia achieved | Drug | duration of disease |
Primary outcome
fasting plasma glucose after insulin therapy
Time frame: 10 hour
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 26 Apr 2018.
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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,PhD principal investigator
Ministry of Education
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 Insulin LISPRO in people with Diabetes Mellitus, Type 2, run by Sun Yat-sen 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 0 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: finished, as of the sponsor's last update on 26 Apr 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?
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?
fasting plasma glucose after insulin therapy (time frame: 10 hour). 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 26 Apr 2018.