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The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy

Primary Purpose

Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Add oral hyppoglycemia drug
Add GLP-1 receptor agonist
Change insulin
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • Patients who cannot tolerate FGM;
  • Pregnant or preparing to become pregnant;
  • Considered unsuitable to participate by the investigator.

Sites / Locations

  • Nanjing First Hospital, Nanjing Medical UnivesityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Oral hyppoglycemia drug group

GLP-1RA group

long-acting insulin group

Control group

Arm Description

Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose.

Add GLP-1 receptor agonists to reduce insulin dose.

Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs

continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control.

Outcomes

Primary Outcome Measures

Insulin autoimmune antibody
The change of insulin autoimmune antibody

Secondary Outcome Measures

HbA1c
The change of glycated hemoglobin
Time in range
The change of time in range
Time below range
The change of time below range
B cell
the change of B cell subsets
T cell
the change of T cell subsets

Full Information

First Posted
October 11, 2022
Last Updated
October 11, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05578352
Brief Title
The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy
Official Title
The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral hyppoglycemia drug group
Arm Type
Active Comparator
Arm Description
Oral hyppoglycemia drugs, including metforemin, acarbose, dipeptidyl peptidase 4 inhibitors, or SGLT2-ihibitors, are added to reduce insulin dose.
Arm Title
GLP-1RA group
Arm Type
Active Comparator
Arm Description
Add GLP-1 receptor agonists to reduce insulin dose.
Arm Title
long-acting insulin group
Arm Type
Active Comparator
Arm Description
Change premix insulin to long-acting insulin plus oral hyppoglycemia drugs
Arm Title
Control group
Arm Type
No Intervention
Arm Description
continue the present premix insulin treatment, adjust insulin dose according to the bloog glucose profile in FGM to improve glycemic control.
Intervention Type
Other
Intervention Name(s)
Add oral hyppoglycemia drug
Intervention Description
Oral hypoglycemic drugs with insulin sensitization effect are added, reduce insulin dose according to blood glucose
Intervention Type
Other
Intervention Name(s)
Add GLP-1 receptor agonist
Intervention Description
Add GLP-1 receptor agonist and reduce insulin dose according to blood glucose
Intervention Type
Other
Intervention Name(s)
Change insulin
Intervention Description
Change premix insulin to long-acting insulin
Primary Outcome Measure Information:
Title
Insulin autoimmune antibody
Description
The change of insulin autoimmune antibody
Time Frame
3 month
Secondary Outcome Measure Information:
Title
HbA1c
Description
The change of glycated hemoglobin
Time Frame
3 month
Title
Time in range
Description
The change of time in range
Time Frame
3 month
Title
Time below range
Description
The change of time below range
Time Frame
3 month
Title
B cell
Description
the change of B cell subsets
Time Frame
3 month
Title
T cell
Description
the change of T cell subsets
Time Frame
3 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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; Patients who cannot tolerate FGM; Pregnant or preparing to become pregnant; Considered unsuitable to participate by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Ma, Professor
Phone
+862552887091
Email
majianhua196503@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma, Professor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing First Hospital, Nanjing Medical Univesity
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma, Professor

12. IPD Sharing Statement

Learn more about this trial

The Exploreration of the Management for the Positive IAA in Patients With Type 2 Diabetes After Premix Insulin Therapy

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