The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy
NCT ID: NCT05578352
Last Updated: 2022-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-08-05
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral hyppoglycemia drug group
Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose.
Add oral hyppoglycemia drug
Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose
GLP-1RA group
Add GLP-1 receptor agonists to reduce insulin dose.
Add GLP-1 receptor agonist
Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose
long-acting insulin group
Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs
Change insulin
Change premix insulin to long-acting insulin
Control group
continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control.
No interventions assigned to this group
Interventions
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Add oral hyppoglycemia drug
Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose
Add GLP-1 receptor agonist
Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose
Change insulin
Change premix insulin to long-acting insulin
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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;
* Patients who cannot tolerate FGM;
* Pregnant or preparing to become pregnant;
* Considered unsuitable to participate by the investigator.
ALL
No
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Jianhua Ma, Professor
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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Nanjing First Hospital, Nanjing Medical Univesity
Nanjing, , China
Countries
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Central Contacts
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Facility Contacts
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Jianhua Ma, Professor
Role: primary
Other Identifiers
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KY2022-8-5-01
Identifier Type: -
Identifier Source: org_study_id
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