Diabetes MellitusPhase 4NCT05084079
Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT
A Phase 4 study testing CSII with formula-based initial insulin regimen and CSII with weight-based initial insulin regimen in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Sun Yat-sen University at 1 site in China.
Trial summary
To compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes mellitus(T2DM) patients, in order to investigate the rational of… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
- What is being tested?
- CSII with formula-based initial insulin regimen and CSII with weight-based initial insulin regimen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Nov 2021to Oct 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed type 2 diabetes (1999 World Health Organization standard);
- Type 2 diabetic patients who have never received any hypoglycemic therapy (including oral hypoglycemic agents, Chinese medicine , and insulin);
- Body mass index (BMI) between 20-35 kg/m2;
- Fasting plasma glucose (FPG) levels between 7.0 -16.7 mmol/L, glycated haemoglobin >7.0%;
- Willing to receive CSII intensive treatment during hospitalization and monitoring blood glucose 8 times per day.
Who cannot join
- Type 1 diabetes or special type of diabetes;
- Acute complications of diabetes: ketoacidosis, hyperosmolar coma, lactic acidosis, etc.;
- Severe macrovascular complications: acute cerebral vascular accidents, acute coronary syndromes, peripheral arterial disease requiring vascular intervention or amputees for hospitalization occur within 12 months before selection;
- Severe microvascular complications: proliferative phase retinopathy; urinary albumin excretion rate(AER)> 300 mg/g or urinary protein Positive, quantitative> 0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
- Obvious liver and kidney dysfunction: alanine aminotransferase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine greater than 150 umol/L or creatinine clearance less than 50 mL/min;
- Significant increase in blood pressure: blood pressure continued to be higher than 180/110 mmHg;
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- Significant anemia: hemoglobin <100g /L may require regular blood transfusions;
- Use of drugs that may affect blood glucose during 12 weeks, such as oral/intravenous corticosteroids, growth hormone, estrogen/progestogen, high-dose diuretics, antipsychotics, etc. Low-dose diuretics for antihypertensive purposes (hydrochlorothiazide <25 mg/d, indapamide ≤ 1.5 mg/d), and physiological quantities of thyroid hormones used for replacement therapy are not limited to this;
- Effects associated with other underlying diseases influenced the observation of blood glucose, such as systemic infection or severe comorbidity, malignancy or chronic diarrhea, uncontrolled endocrine gland function abnormalities, chronic cardiac insufficiency (grade III and above), psychosis, or pregnant;
- The patients does not cooperate, or the investigator judges that it may be difficult to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Yanbing Li, MD,PhD, 8602087334331, easd04lyb@126.com
Yanbing Li, MD,PhD
About this study
Official title: The Impact of Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in Short-term Intensive Insulin Therapy(SIIT)
To compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes mellitus(T2DM) patients, in order to investigate the rational of formula based initiation regimen.
Read the detailed description
Diabetes has become one of the major chronic non-communicable diseases. Its prevalence was rising in these years. Short-term intensive insulin therapy can improve the β-cell function and nearly half of the patients can live with long-term glycemic remission. It has therefore become the recommended treatment for the newly diagnosis T2DM patients with high blood glucose. However, due to the glycemic goal for intensive therapy is strict, it's important to find out a suitable initial insulin regimen for continuous subcutaneous insulin infusion(CSII) with which patients can achieve euglycemia safely, stably and rapidly. In previous study, the investigators found out that the total daily insulin dose at the first day when euglycemia was achieved（TDD-1） was associated with weight, waist circumference, triglycerides and fasting blood glucose levels. According to this, the investigators figured out a formula for estimation of insulin dose for the short-term intensive insulin therapy in patients with newly diagnosed T2DM. However, its feasibility needs to be further verified. Therefore, the investigators conducted this prospective randomized controlled study to compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes patients, in order to investigate the rational of formula based initiation regimen.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
- Being tested
- CSII with formula-based initial insulin regimen, CSII with weight-based initial insulin regimen
- Keywords
- Short-term intensive insulin therapy, Insulin dose, Time to glycemic goal, Hypoglycemic, Glycemic variability
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSII with formula-based initial insulin regimenDrug
Also called Formula-based regimen
Initial total daily insulin dose(TDD) for CSII was calculated with a formula :（estimate TDD-1(eTDD-1) = 0.35× body weight (kg) + 2.05× FPG (mmol/L) + 4.24×triglyceride(mmol/L) + 0.55× waist circumference (cm) - 49.1）, 42% of which was assigned as total basal dose and 58% as total premeal dose, with the pre-meal doses divided into 30:35:35 for breakfast, lunch and dinner.
CSII with weight-based initial insulin regimenDrug
Also called Weight-based regimen
TDD for CSII was started with 0.5 IU/kg, 50% of which was assigned as total basal dose and 50% as total premeal dose, and the total pre-meal dose was divided equally before each meal.
| Study group | Role | What they receive |
|---|---|---|
| Formula-based | Experimental | Initial insulin regimen was decided according to the formula developed by the investigators previously. Receives: Drug: CSII with formula-based initial insulin regimen |
| Weight-based | Placebo comparator | Initial insulin regimen was decided according to current guidelines. Receives: Drug: CSII with weight-based initial insulin regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to glycemic goal
After CSII begin, the time(days) to reach glycemic goal of each patients. The glycemic goal defined as at least six out of eight-point fingertip blood glucose meet the standard that fasting blood glucose(FBG) or non-postprandial blood glucose is between 4.4-6.0 mmol/L and 2h postprandial blood glucose(PBG) is between 4.4-8.0 mmol/L.
Measured: 1 year
Secondary outcomes (5)
Incidence of hypoglycemia
Differences in incidence of hypoglycemia among treatment arms at the end of study.
Measured: 1 year
Change of blood glucose fluctuations
Differences in blood glucose fluctuations among treatment arms at the end of study.
Measured: 1 year
Change of β cell function
Differences in β-cell indicators among treatment arms at the end of study.
Measured: 1 year
Change of insulin sensitivity
Differences in insulin sensitivity indicators among treatment arms at the end of study.
Measured: 1 year
Change of insulin dosage
Differences in insulin dosage among treatment arms at the end of study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- 56 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
- Investigators
- Yanbing Li, MD,PhD, Principal investigator, endocrinology department of the first affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084079
- Sponsor's protocol ID
- 2021526
- Status last verified
- Oct 2021
- First submitted
- 26 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu L, Ke W, Wan X, Zhang P, Cao X, Deng W, Li Y. Insulin requirement profiles of short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes and its association with long-term glycemic remission. Diabetes Res Clin Pract. 2015 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21.
PubMed 25765670
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in Short-term Intensive Insulin Therapy(SIIT)
- ClinicalTrials.gov ID
- NCT05084079
- Acronym / sponsor ID
- 2021526
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases
- Keywords
- Short-term intensive insulin therapy, Insulin dose, Time to glycemic goal, Hypoglycemic, Glycemic variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 19 Oct 2021 (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.
To compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes mellitus(T2DM) patients, in order to investigate the rational of formula based initiation regimen.
Detailed description
Diabetes has become one of the major chronic non-communicable diseases. Its prevalence was rising in these years. Short-term intensive insulin therapy can improve the β-cell function and nearly half of the patients can live with long-term glycemic remission. It has therefore become the recommended treatment for the newly diagnosis T2DM patients with high blood glucose. However, due to the glycemic goal for intensive therapy is strict, it's important to find out a suitable initial insulin regimen for continuous subcutaneous insulin infusion(CSII) with which patients can achieve euglycemia safely, stably and rapidly. In previous study, the investigators found out that the total daily insulin dose at the first day when euglycemia was achieved（TDD-1） was associated with weight, waist circumference, triglycerides and fasting blood glucose levels. According to this, the investigators figured out a formula for estimation of insulin dose for the short-term intensive insulin therapy in patients with newly diagnosed T2DM. However, its feasibility needs to be further verified. Therefore, the investigators conducted this prospective randomized controlled study to compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes patients, in order to investigate the rational of formula based initiation regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formula-based | Experimental | Drug: CSII with formula-based initial insulin regimenInitial insulin regimen was decided according to the formula developed by the investigators previously. |
| Weight-based | Placebo comparator | Drug: CSII with weight-based initial insulin regimenInitial insulin regimen was decided according to current guidelines. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed type 2 diabetes (1999 World Health Organization standard);
- Type 2 diabetic patients who have never received any hypoglycemic therapy (including oral hypoglycemic agents, Chinese medicine , and insulin);
- Body mass index (BMI) between 20-35 kg/m2;
- Fasting plasma glucose (FPG) levels between 7.0 -16.7 mmol/L, glycated haemoglobin >7.0%;
- Willing to receive CSII intensive treatment during hospitalization and monitoring blood glucose 8 times per day.
Key exclusion criteria (10 listed)
- Type 1 diabetes or special type of diabetes;
- Acute complications of diabetes: ketoacidosis, hyperosmolar coma, lactic acidosis, etc.;
- Severe macrovascular complications: acute cerebral vascular accidents, acute coronary syndromes, peripheral arterial disease requiring vascular intervention or amputees for hospitalization occur within 12 months before selection;
- Severe microvascular complications: proliferative phase retinopathy; urinary albumin excretion rate(AER)> 300 mg/g or urinary protein Positive, quantitative> 0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
- Obvious liver and kidney dysfunction: alanine aminotransferase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine greater than 150 umol/L or creatinine clearance 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 |
|---|---|---|
| CSII with formula-based initial insulin regimenAlso: Formula-based regimenInitial total daily insulin dose(TDD) for CSII was calculated with a formula :（estimate TDD-1(eTDD-1) = 0.35× body weight (kg) + 2.05× FPG (mmol/L) + 4.24×triglyceride(mmol/L) + 0.55× waist circumference (cm) - 49.1）, 42% of which was assigned as total basal dose and 58% as total premeal dose, with the pre-meal doses divided into 30:35:35 for breakfast, lunch and dinner. | Drug | Formula-based |
| CSII with weight-based initial insulin regimenAlso: Weight-based regimenTDD for CSII was started with 0.5 IU/kg, 50% of which was assigned as total basal dose and 50% as total premeal dose, and the total pre-meal dose was divided equally before each meal. | Drug | Weight-based |
Primary outcome
The time to glycemic goal
Time frame: 1 year
After CSII begin, the time(days) to reach glycemic goal of each patients. The glycemic goal defined as at least six out of eight-point fingertip blood glucose meet the standard that fasting blood glucose(FBG) or non-postprandial blood glucose is between 4.4-6.0 mmol/L and 2h postprandial blood glucose(PBG) is between 4.4-8.0 mmol/L.
5 secondary outcomes
Incidence of hypoglycemia
Time frame: 1 year
Change of blood glucose fluctuations
Time frame: 1 year
Change of β cell function
Time frame: 1 year
Change of insulin sensitivity
Time frame: 1 year
Change of insulin dosage
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Results publication: PubMed 25765670Liu L, Ke W, Wan X, Zhang P, Cao X, Deng W, Li Y. Insulin requirement profiles of short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes and its association with long-term glycemic remission. Diabetes Res Clin Pract. 2015 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21.
- Individual participant dataSharing planned: Undecided
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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.
Yanbing Li, MD,PhD principal investigator
endocrinology department of the first affiliated hospital of Sun Yat-sen University
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 CSII with formula-based initial insulin regimen and CSII with weight-based initial insulin regimen in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, 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 10 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 19 Oct 2021. 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. 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?
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?
Contact Xinwei Huang, MA (+8613480264781, 17301500@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to glycemic goal (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05084079, which also lists 1 linked publication.
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 19 Oct 2021.