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

Last updated: October 8, 2021
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT05084079
2021526
  • Ages 20-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed type 2 diabetes (1999 World Health Organization standard);
  • Type 2 diabetic patients who have never received any hypoglycemic therapy (includingoral 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 monitoringblood glucose 8 times per day.

Exclusion

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 coronarysyndromes, peripheral arterial disease requiring vascular intervention or amputees forhospitalization occur within 12 months before selection;
  • Severe microvascular complications: proliferative phase retinopathy; urinary albuminexcretion rate(AER)> 300 mg/g or urinary protein Positive, quantitative> 0.5 g/d;uncontrolled painful diabetic neuropathy and significant diabetic autonomicneuropathy;
  • Obvious liver and kidney dysfunction: alanine aminotransferase ≥ 2.5 times the upperlimit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serumcreatinine 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/intravenouscorticosteroids, 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 ofthyroid hormones used for replacement therapy are not limited to this;
  • Effects associated with other underlying diseases influenced the observation of bloodglucose, such as systemic infection or severe comorbidity, malignancy or chronicdiarrhea, uncontrolled endocrine gland function abnormalities, chronic cardiacinsufficiency (grade III and above), psychosis, or pregnant;
  • The patients does not cooperate, or the investigator judges that it may be difficultto complete the study.

Study Design

Total Participants: 56
Study Start date:
November 01, 2021
Estimated Completion Date:
October 31, 2022

Study 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.

Connect with a study center

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

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

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