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

NCT ID: NCT03220919

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-02-28

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.

Conditions

Efficacy, Self; Adverse Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Weight-based

Weight-based insulin insulin titration regimen

Group Type: EXPERIMENTAL

Weight-based

Intervention Type: OTHER

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

Glucose level-based

Glucose level-based insulin titration regimen

Group Type: PLACEBO_COMPARATOR

Glucose level-based

Intervention Type: OTHER

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

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

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wangen Li, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaodan Zhang, MD

Role: CONTACT

sysuzhangxd@163.com

86-20-34152032

Wangen Li, MD

Role: CONTACT

liwg660@126.com

86-20-34152032

Facility Contacts

Wangen Li

Role: primary

86-20-34152032

References

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.

Reference Type: DERIVED

PMID: 32933950 (View on PubMed)

Other Identifiers

weightbased

Identifier Type: -

Identifier Source: org_study_id