Adverse Effect, Efficacy, Self
Conditions
Keywords
Insulin, Type 2 diabetes
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.
Interventions
OTHERWeight-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
OTHERGlucose 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.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia | at discharge, an average of 9 days | Incidence of hypoglycemia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | at discharge, an average of 9 days | Other adverse effects except hypoglycemia |
Countries
China
Contacts
Primary ContactXiaodan Zhang, MD
Backup ContactWangen Li, MD
Outcome results
None listed