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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03220919
Other study ID # weightbased
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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