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

NCT05084079 | Unknown Phase 4

• 1 other identifier: 2021526
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of hypoglycemia

  1 year

• Change of blood glucose fluctuations

  1 year

• Change of β cell function

  1 year

• Change of insulin sensitivity

  1 year

• Change of insulin dosage

  1 year

Study Arms (2)

Formula-based

EXPERIMENTAL

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

Drug: CSII with formula-based initial insulin regimen

Weight-based

PLACEBO COMPARATOR

Initial insulin regimen was decided according to current guidelines.

Drug: CSII with weight-based initial insulin regimen

Interventions

CSII with formula-based initial insulin regimen DRUG

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.

Also known as: Formula-based regimen

Formula-based

CSII with weight-based initial insulin regimen DRUG

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.

Also known as: Weight-based regimen

Weight-based

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

RECRUITING

Related 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 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21.

  PMID: 25765670 RESULT

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Yanbing Li, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinwei Huang, MA

CONTACT

+8613480264781; 17301500@qq.com

Liehua Liu, PhD

CONTACT

+8613751748843; turkey310@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology and Metabolism Department

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: October 19, 2021
• Study Start: November 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

CN (1)