Efﬁcacy and Safety of Weight-Based Insulin Titration Regimen in Hospitalized Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The investigators propose to use a weight-based regimen consisting of basal-bolus insulin and preprandial rapid-acting insulin and to test its efficacy and safety in controlling blood glucose in hospitalized patients with type 2 diabetes.

Detailed Description
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Patients with type 2 diabetes are randomly assigned by computer-generated block randomization to receive either weight-based or glucose level-based titration regimen. All antidiabetic drugs are discontinued on admission. Starting dose: Total daily insulin is 0.4U/kg. Half is given as glargine and the remainder as aspart which is divided into three equal parts used for three pre-meal boluses. Titration: Weight-based insulin titration regimen: Glargine titration: 0.1U/kg per day when fasting blood glucose (FBG) is over 8.0 mmol/L. Aspart titration: total dose 0.1U/kg per day when next pre-meal blood glucose (BG) is over 8.0 mmol/L, which is divided into three equal parts adding to three pre-meal boluses. Glucose level- based titration regimen: Glargine titration: 4, 6, or 8 U when FBG is, respectively, within the following ranges: 8.0-8.9, 9.0-9.9, >10.0 mmol/L. Aspart titration: 1, 3, 5, 7 or 8 U when next pre-meal BG is, respectively, within the following ranges: 8.0-10.9, 11.0-13.9, 14.0-16.9, 17.0-19.9, > 20 mmol/L.

Official Title
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Efﬁcacy and Safety of Weight-Based Insulin Titration (WEB-IT) Regimen Compared With Glucose Level-based Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Controlled Study

Conditions
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Efficacy, Self, Adverse Effect

Intervention / Treatment
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* Other: Weight-based
* Other: Glucose level-based


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 80 years with type 2 diabetes admitted to Endocrinology wards. Exclusion Criteria: Patients with hepatic or renal dysfunction, cancer, or diabetic ketoacidosis; Patients who are pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight-based<br>Weight-based insulin insulin titration regimen | Other: Weight-based<br>* Glargine titration: 0.1U/kg per day when FBG is over 8.0 mmol/L. Aspart titration: total dose 0.1U/kg per day when next pre-meal BG is over 8.0 mmol/L, which is divided into three equal parts adding to three pre-meal boluses<br>|
| Placebo Comparator: Glucose level-based<br>Glucose level-based insulin titration regimen | Other: Glucose level-based<br>* Glargine titration: 4, 6, or 8 U when FBG is, respectively, within the following ranges: 8.0-8.9, 9.0-9.9, >10.0 mmol/L. Aspart titration: 1, 3, 5, 7 or 8 U when next pre-meal BG is, respectively, within the following ranges: 8.0-10.9, 11.0-13.9, 14.0-16.9, 17.0-19.9, > 20 mmol/L.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration | Duration to achieve BG targets, including three pre-meal BG and bedtime BG | at discharge, an average of 9 days | 
| Doses | Doses of insulin glargine and insulin aspart when the BG targets are achieved | at discharge, an average of 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia | Incidence of hypoglycemia | at discharge, an average of 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin, Type 2 diabetes