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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084079
• Other study ID #: 2021526
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2021
• Est. completion date: October 2022

Study information

• Verified date: October 2021
• Source: Sun Yat-sen University
• Contact: Xinwei Huang, MA
• Phone: +8613480264781
• Email: 17301500[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 formula based initiation regimen.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Metabolic Disease
• Metabolic Diseases

Intervention

Drug:
• CSII with formula-based initial insulin 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 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.

Locations

Country	Name	City	State
China	endocrinology department of the first affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	Incidence of hypoglycemia	Differences in incidence of hypoglycemia among treatment arms at the end of study.	1 year
Secondary	Change of blood glucose fluctuations	Differences in blood glucose fluctuations among treatment arms at the end of study.	1 year
Secondary	Change of ß cell function	Differences in ß-cell indicators among treatment arms at the end of study.	1 year
Secondary	Change of insulin sensitivity	Differences in insulin sensitivity indicators among treatment arms at the end of study.	1 year
Secondary	Change of insulin dosage	Differences in insulin dosage among treatment arms at the end of study.	1 year