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

Phase 4

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Metabolic Disease
• Interventions: Drug: CSII with formula-based initial insulin regimen; Drug: CSII with weight-based initial insulin regimen

• Registration Number: NCT05084079
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2021-09-26
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Study Start: 2021-11
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formula-based	CSII with formula-based initial insulin regimen	Initial insulin regimen was decided according to the formula developed by the investigators previously.
Weight-based	CSII with weight-based initial insulin regimen	Initial insulin regimen was decided according to current guidelines.

Primary Outcome Measures

Name	Time	Method
The time to glycemic goal	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoglycemia	1 year	Differences in incidence of hypoglycemia among treatment arms at the end of study.
Change of insulin sensitivity	1 year	Differences in insulin sensitivity indicators among treatment arms at the end of study.
Change of blood glucose fluctuations	1 year	Differences in blood glucose fluctuations among treatment arms at the end of study.
Change of β cell function	1 year	Differences in β-cell indicators among treatment arms at the end of study.
Change of insulin dosage	1 year	Differences in insulin dosage among treatment arms at the end of study.

Trial Locations

Locations (1)

endocrinology department of the first affiliated hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China