Type 2 Diabetes MellitusNCT05578352
The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy
A study testing Add oral hyppoglycemia drug, Add GLP-1 receptor agonist and Change insulin in people with Type 2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Premix insulin is widely used, with high proportion of positive insulin autoimmune antibody in patients with type 2 diabetes. The positive insulin autoimmune antibody may affect blood glucose control. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Add oral hyppoglycemia drug, Add GLP-1 receptor agonist and Change insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2022to 31 Jan 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes;
- Treated with premix insulin, two or three injections a day, single drug or combination of oral hypoglycemic drugs;
- The treatment regimen was stable for more than 2 months;
- With positive insulin antibody
Who cannot join
- Patients treated with GLP-1 agonist in the last 3 months;
- Allergic to insulin;
- Impaired liver and renal function (ALT 2.5 times higher than the upper limit of normal value; serum creatinine was 1.3 times higher than the upper limit of normal);
- A history of drug abuse and alcohol dependence;
- Used systemic glucocorticoids therapy in recent 3 months;
- Patients with infection or stress within four weeks;
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- Patients who cannot tolerate FGM;
- Pregnant or preparing to become pregnant;
- Considered unsuitable to participate by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical Univesity
Nanjing
Jianhua Ma, Professor
About this study
Premix insulin is widely used, with high proportion of positive insulin autoimmune antibody in patients with type 2 diabetes. The positive insulin autoimmune antibody may affect blood glucose control. We aim to explore the management for the positive insulin autoimmune antibody and blood glucose control in these patients, and investigate the immune cells changes with the change of different glucose lowering drugs.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Add oral hyppoglycemia drug, Add GLP-1 receptor agonist, Change insulin
- 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.
Add oral hyppoglycemia drugOther
Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose
Add GLP-1 receptor agonistOther
Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose
Change insulinOther
Change premix insulin to long-acting insulin
| Study group | Role | What they receive |
|---|---|---|
| Oral hyppoglycemia drug group | Active comparator | Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose. Receives: Other: Add oral hyppoglycemia drug |
| GLP-1RA group | Active comparator | Add GLP-1 receptor agonists to reduce insulin dose. Receives: Other: Add GLP-1 receptor agonist |
| long-acting insulin group | Active comparator | Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs Receives: Other: Change insulin |
| Control group | No intervention | continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin autoimmune antibody
The change of insulin autoimmune antibody
Measured: 3 month
Secondary outcomes (5)
HbA1c
The change of glycated hemoglobin
Measured: 3 month
Time in range
The change of time in range
Measured: 3 month
Time below range
The change of time below range
Measured: 3 month
B cell
the change of B cell subsets
Measured: 3 month
T cell
the change of T cell subsets
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start5 Aug 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, Professor, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578352
- Sponsor's protocol ID
- KY2022-8-5-01
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy
- ClinicalTrials.gov ID
- NCT05578352
- Acronym / sponsor ID
- KY2022-8-5-01
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 13 Oct 2022 (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.
Premix insulin is widely used, with high proportion of positive insulin autoimmune antibody in patients with type 2 diabetes. The positive insulin autoimmune antibody may affect blood glucose control. We aim to explore the management for the positive insulin autoimmune antibody and blood glucose control in these patients, and investigate the immune cells changes with the change of different glucose lowering drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral hyppoglycemia drug group | Active comparator | Other: Add oral hyppoglycemia drugOral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose. |
| GLP-1RA group | Active comparator | Other: Add GLP-1 receptor agonistAdd GLP-1 receptor agonists to reduce insulin dose. |
| long-acting insulin group | Active comparator | Other: Change insulinChange premix insulin to long-acting insulin plus oral hyppoglycemia drugs |
| Control group | No intervention | –continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes;
- Treated with premix insulin, two or three injections a day, single drug or combination of oral hypoglycemic drugs;
- The treatment regimen was stable for more than 2 months;
- With positive insulin antibody
Key exclusion criteria (9 listed)
- Patients treated with GLP-1 agonist in the last 3 months;
- Allergic to insulin;
- Impaired liver and renal function (ALT 2.5 times higher than the upper limit of normal value; serum creatinine was 1.3 times higher than the upper limit of normal);
- A history of drug abuse and alcohol dependence;
- Used systemic glucocorticoids therapy in recent 3 months;
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 |
|---|---|---|
| Add oral hyppoglycemia drugOral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose | Other | Oral hyppoglycemia drug group |
| Add GLP-1 receptor agonistAdd GLP-1 receptor agonist and reduce insulin dose according to blood glucose | Other | GLP-1RA group |
| Change insulinChange premix insulin to long-acting insulin | Other | long-acting insulin group |
Primary outcome
Insulin autoimmune antibody
Time frame: 3 month
The change of insulin autoimmune antibody
5 secondary outcomes
HbA1c
Time frame: 3 month
Time in range
Time frame: 3 month
Time below range
Time frame: 3 month
B cell
Time frame: 3 month
T cell
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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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.
Jianhua Ma, Professor study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Add oral hyppoglycemia drug, Add GLP-1 receptor agonist and Change insulin in people with Type 2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical 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 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. 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.
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 Jianhua Ma, Professor (+862552887091, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin autoimmune antibody (time frame: 3 month). 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 13 Oct 2022.