Clinical trial NCT03220919: Efﬁcacy and Safety of Weight-Based Insulin Titration Regimen in Hospitalized Patients With Type 2 Diabetes
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
Overall status: UNKNOWN
Phase: NA
Conditions: Efficacy, Self
Adverse Effect
Keywords: Insulin
Type 2 diabetes
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Duration
timeFrame: at discharge, an average of 9 days
measure: Doses
timeFrame: at discharge, an average of 9 days
Secondary outcomes:
measure: Hypoglycemia
timeFrame: at discharge, an average of 9 days
Other outcomes:
measure: Adverse effects
timeFrame: at discharge, an average of 9 days
Locations:
city: Guangzhou
country: China
facility: the Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Wangen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.