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

Adverse Effect Clinical Trial

— WEB-IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03220919
• Other study ID #: weightbased
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2017
• Last updated: July 17, 2017
• Start date: June 1, 2017
• Est. completion date: February 2019

Study information

• Verified date: July 2017
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Xiaodan Zhang, MD
• Phone: 86-20-34152032
• Email: sysuzhangxd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Effect
• Diabetes Mellitus, Type 2
• Efficacy, Self

Intervention

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
• 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.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects	Other adverse effects except hypoglycemia	at discharge, an average of 9 days
Primary	Duration	Duration to achieve BG targets, including three pre-meal BG and bedtime BG	at discharge, an average of 9 days
Primary	Doses	Doses of insulin glargine and insulin aspart when the BG targets are achieved	at discharge, an average of 9 days
Secondary	Hypoglycemia	Incidence of hypoglycemia	at discharge, an average of 9 days