Newly Diagnosed Type 2 DiabetesPhase 4NCT03972982
Effects of Structured Simplified Short-term Intensive Insulin Therapy on Long-term Glycemic Remission
A Phase 4 study testing Simplified intensive insulin therapy regimen and Traditional Short-term Intensive insulin therapy in people with Newly Diagnosed Type 2 Diabetes and Simplified Short-term Intensive Insulin Therapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
Short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Newly Diagnosed Type 2 Diabetes, Simplified Short-term Intensive Insulin Therapy, Glycemic Remission
- What is being tested?
- Simplified intensive insulin therapy regimen and Traditional Short-term Intensive insulin therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Dec 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed type 2 diabetes with no prior hypoglycemic agents application, or on hyperglycemic monotherapy for less than 1 week;
- GHbA1c ≥ 9%
- Body mass index between 20-35kg/m2
- Capable to use wearable devices and mobile Apps;
- willling to follow the study protocol and data collection.
Who cannot join
- Type 1 diabetes or specific types of diabetes;
- Allergic or intolercance to medicine used in the study;
- Acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
- Severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria,uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy;
- Glomerular filtration rate less than 50 ml/min
- ALT >2.5 times of the upper limit of normal (ULN), or bilirubin > 1.5 times of ULN；
Show all 15Show fewer
- Significant Macrovascular disease:acute cerebrovascular accident, acute coronary syndrome or peripheral artery disease that required vascular intervention or amputation 12 months before enrollment;
- Poor blood pressure control (systolic blood pressure≥180mmHg and/or sitting diastolic blood pressure ≥110mmHg) and unable to control under 160/110mmhg within 1 week;
- Hemoglubin level < 100g/L or required regular blood transfusion;
- Chronic cardiac dysfunction with NYHA grade III or above;
- Use of medicines that affect blood glucose for a cumulative time of more than 1 week within the prior 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ < 25mg/d, indapamide < 1.5mg/d) and physiologic replacement of thyroid hormone are allowed;
- Serious systemic disease or malignant tumor, chronic diarrhea, etc；
- Uncontrolled abnormalty in endocrine glands (Cushing's syndrome, hyperthyroidism, etc.);
- Any factors that may affect the participation of the subject in the study or the evaluation of the results；
- Pregnancy or planned pregnancy, lactation subjects.
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: Induction of Long-term Glycemic Remission Via Structured Simplified Short-term Intensive Insulin Therapy in Patients With Newly Diagnosed Type 2 Diabetes: a Multiple Centered, Randomised Controlled Trial.
Short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. This study aims to invesitgate whether simplified regimen is non-inferior to traditional regimen in achieving long-term glycemic remisson.
- Conditions
- Newly Diagnosed Type 2 Diabetes, Simplified Short-term Intensive Insulin Therapy, Glycemic Remission
- Being tested
- Simplified intensive insulin therapy regimen, Traditional Short-term Intensive insulin therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified intensive insulin therapy regimenDrug
Short-term continuous subcutaneous insulin infusion to maitain near normoglycemica for 1 week, thereafter basal insulin and metformin were subsequently used. Wearable devices and smart apps will be used for lifestyle modification.
Traditional Short-term Intensive insulin therapyDrug
Short-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up
| Study group | Role | What they receive |
|---|---|---|
| Simplified regimen group | Experimental | Short-term continuous subcutaneous insulin infusion will be adminstrated to maintained euglycemia for 1 week，Then subsequent therapy using basal insulin plus metformin will be administrated. After withdrawal of the medicine, wearable devices and smart apps will be used for long-term management. Receives: Drug: Simplified intensive insulin therapy regimen |
| Routine group | Active comparator | Inpaitent short-term continuous subcutaneous insulin infusion will be administered to maintained euglycemia for 2 weeks, Then subjects will be follow-up routinely. Receives: Drug: Traditional Short-term Intensive insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission rate
Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents
Measured: 24 weeks after withdrawal of the medical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Type 2 DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972982
- Sponsor's protocol ID
- 2018YFC1314102
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2019
- Last updated
- 4 Jun 2019
- 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 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Long-term Glycemic Remission Via Structured Simplified Short-term Intensive Insulin Therapy in Patients With Newly Diagnosed Type 2 Diabetes: a Multiple Centered, Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03972982
- Acronym / sponsor ID
- 2018YFC1314102
- Conditions
- Newly Diagnosed Type 2 Diabetes, Simplified Short-term Intensive Insulin Therapy, Glycemic Remission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Jun 2019 (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.
Short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. This study aims to invesitgate whether simplified regimen is non-inferior to traditional regimen in achieving long-term glycemic remisson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simplified regimen group | Experimental | Drug: Simplified intensive insulin therapy regimenShort-term continuous subcutaneous insulin infusion will be adminstrated to maintained euglycemia for 1 week，Then subsequent therapy using basal insulin plus metformin will be administrated. After withdrawal of the medicine, wearable devices and smart apps will be used for long-term management. |
| Routine group | Active comparator | Drug: Traditional Short-term Intensive insulin therapyInpaitent short-term continuous subcutaneous insulin infusion will be administered to maintained euglycemia for 2 weeks, Then subjects will be follow-up routinely. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- newly diagnosed type 2 diabetes with no prior hypoglycemic agents application, or on hyperglycemic monotherapy for less than 1 week;
- GHbA1c ≥ 9%
- Body mass index between 20-35kg/m2
- Capable to use wearable devices and mobile Apps;
- willling to follow the study protocol and data collection.
Key exclusion criteria (15 listed)
- Type 1 diabetes or specific types of diabetes;
- Allergic or intolercance to medicine used in the study;
- Acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
- Severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria,uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy;
- Glomerular filtration rate less than 50 ml/min
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 |
|---|---|---|
| Simplified intensive insulin therapy regimenShort-term continuous subcutaneous insulin infusion to maitain near normoglycemica for 1 week, thereafter basal insulin and metformin were subsequently used. Wearable devices and smart apps will be used for lifestyle modification. | Drug | Simplified regimen group |
| Traditional Short-term Intensive insulin therapyShort-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up | Drug | Routine group |
Primary outcome
remission rate
Time frame: 24 weeks after withdrawal of the medical intervention
Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Simplified intensive insulin therapy regimen and Traditional Short-term Intensive insulin therapy in people with Newly Diagnosed Type 2 Diabetes and Simplified Short-term Intensive Insulin Therapy, 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 5 inclusion and 15 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 4 Jun 2019. 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?
Results are not available in the source record.
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?
remission rate (time frame: 24 weeks after withdrawal of the medical intervention). 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 4 Jun 2019.