NCT03220919

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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: 1. 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. 2. 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.

Conditions

• Efficacy, Self
• Adverse Effect

Interventions

Type	Name	Description
OTHER	Weight-based	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
OTHER	Glucose level-based	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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-12-01
• Completion: 2019-02-01
• First posted: 2017-07-18
• Last updated: 2017-07-18

Locations

1 site across 1 country: China