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

Primary Purpose

Efficacy, Self, Adverse Effect

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Weight-based
Glucose level-based
Sponsored by
Second Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy, Self focused on measuring Insulin, Type 2 diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Weight-based

Glucose level-based

Arm Description

Weight-based insulin insulin titration regimen

Glucose level-based insulin titration regimen

Outcomes

Primary Outcome Measures

Duration
Duration to achieve BG targets, including three pre-meal BG and bedtime BG
Doses
Doses of insulin glargine and insulin aspart when the BG targets are achieved

Secondary Outcome Measures

Hypoglycemia
Incidence of hypoglycemia

Full Information

First Posted
July 8, 2017
Last Updated
July 17, 2017
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03220919
Brief Title
Efficacy and Safety of Weight-Based Insulin Titration Regimen in Hospitalized Patients With Type 2 Diabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Self, Adverse Effect
Keywords
Insulin, Type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight-based
Arm Type
Experimental
Arm Description
Weight-based insulin insulin titration regimen
Arm Title
Glucose level-based
Arm Type
Placebo Comparator
Arm Description
Glucose level-based insulin titration regimen
Intervention Type
Other
Intervention Name(s)
Weight-based
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Glucose level-based
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration
Description
Duration to achieve BG targets, including three pre-meal BG and bedtime BG
Time Frame
at discharge, an average of 9 days
Title
Doses
Description
Doses of insulin glargine and insulin aspart when the BG targets are achieved
Time Frame
at discharge, an average of 9 days
Secondary Outcome Measure Information:
Title
Hypoglycemia
Description
Incidence of hypoglycemia
Time Frame
at discharge, an average of 9 days
Other Pre-specified Outcome Measures:
Title
Adverse effects
Description
Other adverse effects except hypoglycemia
Time Frame
at discharge, an average of 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodan Zhang, MD
Phone
86-20-34152032
Email
sysuzhangxd@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wangen Li, MD
Phone
86-20-34152032
Email
liwg660@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wangen Li, MD
Organizational Affiliation
Second Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wangen Li
Phone
86-20-34152032

12. IPD Sharing Statement

Citations:
PubMed Identifier
32933950
Citation
Zhang X, Zhang T, Xiang G, Wang W, Li Y, Du T, Zhao Y, Mosha SS, Li W. Comparison of weight-based insulin titration (WIT) and glucose-based insulin titration using basal-bolus algorithm in hospitalized patients with type 2 diabetes: a multicenter, randomized, clinical study. BMJ Open Diabetes Res Care. 2020 Sep;8(1):e001261. doi: 10.1136/bmjdrc-2020-001261.
Results Reference
derived

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

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