Efficacy and Safety of Weight-Based Insulin Titration Regimen in Hospitalized Patients With Type 2 Diabetes
WEB-IT
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 8, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedJuly 18, 2017
July 1, 2017
1.5 years
July 8, 2017
July 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration
Duration to achieve BG targets, including three pre-meal BG and bedtime BG
at discharge, an average of 9 days
Doses
Doses of insulin glargine and insulin aspart when the BG targets are achieved
at discharge, an average of 9 days
Secondary Outcomes (1)
Hypoglycemia
at discharge, an average of 9 days
Other Outcomes (1)
Adverse effects
at discharge, an average of 9 days
Study Arms (2)
Weight-based
EXPERIMENTALWeight-based insulin insulin titration regimen
Glucose level-based
PLACEBO COMPARATORGlucose level-based insulin titration regimen
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Patients aged 18 to 80 years with type 2 diabetes admitted to Endocrinology wards.
You may not qualify if:
- Patients with hepatic or renal dysfunction, cancer, or diabetic ketoacidosis;
- Patients who are pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Related Publications (1)
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.
PMID: 32933950DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wangen Li, MD
Second Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2017
First Posted
July 18, 2017
Study Start
June 1, 2017
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
July 18, 2017
Record last verified: 2017-07