WEB-IT: Efficacy and Safety of Weight-Based Insulin Titration Regimen in Hospitalized Patients With Type 2 Diabetes
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Weight-based Weight-based insulin insulin titration regimen |
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
|
| Placebo Comparator: Glucose level-based Glucose level-based insulin titration regimen |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Hypoglycemia [at discharge, an average of 9 days]
Incidence of hypoglycemia
Other Outcome Measures
- Adverse effects [at discharge, an average of 9 days]
Other adverse effects except hypoglycemia
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
Sponsors and Collaborators
- Second Affiliated Hospital of Guangzhou Medical University
Investigators
- Principal Investigator: Wangen Li, MD, Second Affiliated Hospital of Guangzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- weightbased