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

Not Applicable

• Conditions: Efficacy, Self; Adverse Effect
• Interventions: Other: Weight-based; Other: Glucose level-based

• Registration Number: NCT03220919
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Brief 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.

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-17
• Last Update Submitted: 2017-07-17
• Study First Posted: 2017-07-18
• Last Update Posted: 2017-07-18
• Primary Completion: 2018-12
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight-based	Weight-based	Weight-based insulin insulin titration regimen
Glucose level-based	Glucose level-based	Glucose level-based insulin titration regimen

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia	at discharge, an average of 9 days	Incidence of hypoglycemia

Trial Locations

Locations (1)

the Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China