Diabetes Mellitus, Type 2Early Phase 1NCT04357392
Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome
A Early Phase 1 study testing Prednisone in people with Diabetes Mellitus, Type 2, run by chenfengling.
Trial summary
Diabetic patients who have long-term insulin used can product antibody against exogenous insulin, the investigators named this condition Exogenous insulin antibody syndrome (EIAs). Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2020to 20 May 2023
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diagnosis of type 2 diabetes was in accordance with the WHO diagnostic criteria of diabetes in 1999:fasting blood glucose ≥ 7.0mmol/l and / or blood glucose ≥ 11.1mmol/l in 2 hours after OGTT
- Aged between 30-60 years
- Positive detection of insulin antibody, hyperinsulinemia (refer to WHO standard in 1999, fasting insulin > 15 μ IU / ml or 2h postprandial insulin > 80 μ IU / ml)
- Type 2 diabetes mellitus patients who receiving insulin therapy
- Those meeting all the above standards can be included
Who cannot join
- Patients who had used animal insulin before the study
- Type 1 diabetes, gestational diabetes and special type diabetes
- Diabetic acute complications (ketoacidosis, hyperosmotic nonketotic coma, lactic acidosis) or serious chronic complications ; serious chronic complications (proliferative retinopathy, foot ulcer or gangrene, Complications of heart, brain and kidney)
- Patients with other serious heart disease, endocrine disease, autoimmune or chronic wasting disease
- Patients with severe primary diseases such as liver, kidney and hematopoietic system , Patients with psychosis
- Patients who are using or need to use thiol containing drugs in the near future
- Patients with severe insulin allergy
- Glucocorticoid contraindications (severe psychosis and epilepsy, active peptic ulcer or tuberculosis, recent gastrointestinal anastomosis, fracture, wound repair period, corneal ulcer, adrenocortical hyperfunction, severe hypertension, pregnant women, infection beyond the control of antibiotics, such as varicella, mould infection, etc.)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Effect of Glucocorticoid Intervention on the Improvement of Blood Glucose in Patients With Exogenous Insulin Antibody Syndrome
Diabetic patients who have long-term insulin used can product antibody against exogenous insulin, the investigators named this condition Exogenous insulin antibody syndrome (EIAs). Exogenous insulin antibody can cause blood glucose fluctuation, high blood glucose and refractory hypoglycemia, and have a serious impact on the health of diabetic patients. After adding glucocorticoid, some EIAs patients can reduce insulin dosage, correct hypoglycemia, even eliminate insulin antibody in about half a year, and achieve the goal of blood glucose stability. But up to now, there is no study to evaluate the improvement of blood glucose by glucocorticoid intervention in EIAS patients receiving insulin therapy. This project plans to collect 20 cases of EIAS and carry out a randomized, double-blind, placebo-controlled clinical trial to evaluate the improvement of blood glucose by glucocorticoid intervention.
Read the detailed description
Diabetic patients who have long-term insulin used can product antibody against exogenous insulin, the investigators named this condition Exogenous insulin antibody syndrome (EIAs).Exogenous insulin antibody can lead to serious clinical consequences , such as blood glucose fluctuations, high blood glucose and refractory hypoglycemia, which is not only affect patients' blood glucose control, but also have a serious impact on the health of diabetic patients. Change to the oral antidiabetic drugs, change the insulin type or add glucocorticoids to the patients with serious disease are the main treatments. However, most of these treatment schemes are case reports, and there is no randomized controlled cohort study on the treatment scheme. The biosynthetic human insulin sequence is exactly the same as that of human insulin. Why do some diabetics have insulin antibody? The investigators speculated that insulin antibody production in some patients with EIAs is related to autoimmune disorder. After adding glucocorticoid, some EIAs patients can reduce insulin dosage, correct hypoglycemia, even eliminate insulin antibody in about half a year, and achieve the goal of blood glucose stability. However, there is no study to evaluate the effect of glucocorticoid intervention on the improvement of blood glucose in the EIAs population. This project plans to collect 20 cases of EIAs and carry out a randomized, double-blind, placebo-controlled clinical trial to evaluate the improvement of blood glucose by glucocorticoid intervention, so as to provide scientific basis for the standardized diagnosis and treatment of EIAs.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Prednisone
- Keywords
- Insulin, HbA1c, Exogenous Insulin Antibody Syndrome, Glucocorticoids
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called oral antidiabetic agents, insulin
Prednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoid intervention group | Experimental | prednisone Receives: Drug: Prednisone |
| Placebo control group | Placebo comparator | placebo Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with HbA1c <7% at 12 and 24 weeks
Measured: 24 weeks
Secondary outcomes (1)
Blood glucose fluctuation at 4, 12 and 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start20 May 2020 (estimated)
- Primary completion20 May 2022 (estimated)
- Study completion20 May 2023 (estimated)
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, single center, pragmatic clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- chenfengling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, chenfengling, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Chen, Principal investigator, The Ninth People's Hospital Affiliated to Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357392
- Sponsor's protocol ID
- EIAS2020V4
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Glucocorticoid Intervention on the Improvement of Blood Glucose in Patients With Exogenous Insulin Antibody Syndrome
- ClinicalTrials.gov ID
- NCT04357392
- Acronym / sponsor ID
- EIAS2020V4
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Insulin, HbA1c, Exogenous Insulin Antibody Syndrome, Glucocorticoids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- chenfenglingUniversity, hospital or other
- Study start
- 20 May 2020 (estimated)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 May 2023 (estimated)
- First posted
- 22 Apr 2020 (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.
Diabetic patients who have long-term insulin used can product antibody against exogenous insulin, the investigators named this condition Exogenous insulin antibody syndrome (EIAs). Exogenous insulin antibody can cause blood glucose fluctuation, high blood glucose and refractory hypoglycemia, and have a serious impact on the health of diabetic patients. After adding glucocorticoid, some EIAs patients can reduce insulin dosage, correct hypoglycemia, even eliminate insulin antibody in about half a year, and achieve the goal of blood glucose stability. But up to now, there is no study to evaluate the improvement of blood glucose by glucocorticoid intervention in EIAS patients receiving insulin therapy. This project plans to collect 20 cases of EIAS and carry out a randomized, double-blind, placebo-controlled clinical trial to evaluate the improvement of blood glucose by glucocorticoid intervention.
Detailed description
Diabetic patients who have long-term insulin used can product antibody against exogenous insulin, the investigators named this condition Exogenous insulin antibody syndrome (EIAs).Exogenous insulin antibody can lead to serious clinical consequences , such as blood glucose fluctuations, high blood glucose and refractory hypoglycemia, which is not only affect patients' blood glucose control, but also have a serious impact on the health of diabetic patients. Change to the oral antidiabetic drugs, change the insulin type or add glucocorticoids to the patients with serious disease are the main treatments. However, most of these treatment schemes are case reports, and there is no randomized controlled cohort study on the treatment scheme. The biosynthetic human insulin sequence is exactly the same as that of human insulin. Why do some diabetics have insulin antibody? The investigators speculated that insulin antibody production in some patients with EIAs is related to autoimmune disorder. After adding glucocorticoid, some EIAs patients can reduce insulin dosage, correct hypoglycemia, even eliminate insulin antibody in about half a year, and achieve the goal of blood glucose stability. However, there is no study to evaluate the effect of glucocorticoid intervention on the improvement of blood glucose in the EIAs population. This project plans to collect 20 cases of EIAs and carry out a randomized, double-blind, placebo-controlled clinical trial to evaluate the improvement of blood glucose by glucocorticoid intervention, so as to provide scientific basis for the standardized diagnosis and treatment of EIAs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, single center, pragmatic clinical trial
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid intervention group | Experimental | Drug: Prednisoneprednisone |
| Placebo control group | Placebo comparator | Drug: Prednisoneplacebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The diagnosis of type 2 diabetes was in accordance with the WHO diagnostic criteria of diabetes in 1999:fasting blood glucose ≥ 7.0mmol/l and / or blood glucose ≥ 11.1mmol/l in 2 hours after OGTT
- Aged between 30-60 years
- Positive detection of insulin antibody, hyperinsulinemia (refer to WHO standard in 1999, fasting insulin > 15 μ IU / ml or 2h postprandial insulin > 80 μ IU / ml)
- Type 2 diabetes mellitus patients who receiving insulin therapy
- Those meeting all the above standards can be included
Key exclusion criteria (8 listed)
- Patients who had used animal insulin before the study
- Type 1 diabetes, gestational diabetes and special type diabetes
- Diabetic acute complications (ketoacidosis, hyperosmotic nonketotic coma, lactic acidosis) or serious chronic complications ; serious chronic complications (proliferative retinopathy, foot ulcer or gangrene, Complications of heart, brain and kidney)
- Patients with other serious heart disease, endocrine disease, autoimmune or chronic wasting disease
- Patients with severe primary diseases such as liver, kidney and hematopoietic system , Patients with psychosis
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 |
|---|---|---|
| PrednisoneAlso: oral antidiabetic agents, insulinPrednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks | Drug | Glucocorticoid intervention group, Placebo control group |
Primary outcome
Number of patients with HbA1c <7% at 12 and 24 weeks
Time frame: 24 weeks
1 secondary outcome
Blood glucose fluctuation at 4, 12 and 24 weeks
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
Chen principal investigator
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Prednisone in people with Diabetes Mellitus, Type 2, run by chenfengling.
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 5 inclusion and 8 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 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Chen (021-56691101-6271, cfl1993@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with HbA1c <7% at 12 and 24 weeks (time frame: 24 weeks). 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 24 Apr 2020.