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

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    56
  • sponsor
    Sun Yat-sen University
Updated on 26 October 2021
insulin
body mass index
fasting
type 2 diabetes mellitus
hypoglycemia
plasma glucose
blood glucose monitoring
hypoglycemic agents
oral hypoglycemic

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 -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 achievedTDD-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.

Details
Condition Diabetes (Pediatric), metabolism disorders, Metabolic Disorders, noninsulin-dependent diabetes mellitus, diabetes type 2, type 2 diabetes, type 2 diabetes mellitus, Diabetes Mellitus Types I and II, metabolic diseases, metabolic disease, endocrinopathy, Endocrine disorder, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, NIDDM, Diabetes Mellitus Type 2, endocrine disease, Diabetes Prevention, type ii diabetes, diabetes mellitus (dm), Diabetes Mellitus, Metabolic disorder, endocrine disorders, endocrine diseases
Treatment CSII with formula-based initial insulin regimen, CSII with weight-based initial insulin regimen
Clinical Study IdentifierNCT05084079
SponsorSun Yat-sen University
Last Modified on26 October 2021

Eligibility

Yes No Not Sure

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
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