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Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT

Primary Purpose

Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

CSII with formula-based initial insulin regimen

CSII with weight-based initial insulin regimen

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Short-term intensive insulin therapy, Insulin dose, Time to glycemic goal, Hypoglycemic, Glycemic variability

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Sites / Locations

endocrinology department of the first affiliated hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Formula-based

Weight-based

Arm Description

Initial insulin regimen was decided according to the formula developed by the investigators previously.

Initial insulin regimen was decided according to current guidelines.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of hypoglycemia

Differences in incidence of hypoglycemia among treatment arms at the end of study.

Change of blood glucose fluctuations

Differences in blood glucose fluctuations among treatment arms at the end of study.

Change of β cell function

Differences in β-cell indicators among treatment arms at the end of study.

Change of insulin sensitivity

Differences in insulin sensitivity indicators among treatment arms at the end of study.

Change of insulin dosage

Differences in insulin dosage among treatment arms at the end of study.

Full Information

NCT ID

NCT05084079

First Posted

September 26, 2021

Last Updated

October 8, 2021

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05084079

Brief Title

Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 2021 (Anticipated)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Formula-based

Arm Type

Experimental

Arm Description

Initial insulin regimen was decided according to the formula developed by the investigators previously.

Arm Title

Weight-based

Arm Type

Placebo Comparator

Arm Description

Initial insulin regimen was decided according to current guidelines.

Intervention Type

Drug

Intervention Name(s)

CSII with formula-based initial insulin regimen

Other Intervention Name(s)

Formula-based regimen

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CSII with weight-based initial insulin regimen

Other Intervention Name(s)

Weight-based regimen

Intervention Description

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.

Primary Outcome Measure Information:

Title

The time to glycemic goal

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Incidence of hypoglycemia

Description

Differences in incidence of hypoglycemia among treatment arms at the end of study.

Time Frame

1 year

Title

Change of blood glucose fluctuations

Description

Differences in blood glucose fluctuations among treatment arms at the end of study.

Time Frame

1 year

Title

Change of β cell function

Description

Differences in β-cell indicators among treatment arms at the end of study.

Time Frame

1 year

Title

Change of insulin sensitivity

Description

Differences in insulin sensitivity indicators among treatment arms at the end of study.

Time Frame

1 year

Title

Change of insulin dosage

Description

Differences in insulin dosage among treatment arms at the end of study.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinwei Huang, MA

Phone

+8613480264781

17301500@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Liehua Liu, PhD

Phone

+8613751748843

turkey310@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanbing Li, MD,PhD

Organizational Affiliation

endocrinology department of the first affiliated hospital of Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

endocrinology department of the first affiliated hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanbing Li, MD,PhD

Phone

8602087334331

easd04lyb@126.com

First Name & Middle Initial & Last Name & Degree

Yanbing Li, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25765670

Citation

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.

Results Reference

result

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Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT

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