Efficacy, SelfWEB-ITNCT03220919
Efficacy and Safety of Weight-Based Insulin Titration Regimen in Hospitalized Patients With Type 2 Diabetes
A study testing Weight-based and Glucose level-based in people with Efficacy, Self and Adverse Effect, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Efficacy, Self, Adverse Effect
- What is being tested?
- Weight-based and Glucose level-based
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years with type 2 diabetes admitted to Endocrinology wards.
Who cannot join
- Patients with hepatic or renal dysfunction, cancer, or diabetic ketoacidosis;
- Patients who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Wangen Li, 86-20-34152032
About this study
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
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.
Read the 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.
- Conditions
- Efficacy, Self, Adverse Effect
- Being tested
- Weight-based, Glucose level-based
- Keywords
- Insulin, Type 2 diabetes
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-basedOther
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-basedOther
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 group | Role | What they receive |
|---|---|---|
| Weight-based | Experimental | Weight-based insulin insulin titration regimen Receives: Other: Weight-based |
| Glucose level-based | Placebo comparator | Glucose level-based insulin titration regimen Receives: Other: Glucose level-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration
Duration to achieve BG targets, including three pre-meal BG and bedtime BG
Measured: at discharge, an average of 9 days
Doses
Doses of insulin glargine and insulin aspart when the BG targets are achieved
Measured: at discharge, an average of 9 days
Secondary outcomes (1)
Hypoglycemia
Incidence of hypoglycemia
Measured: at discharge, an average of 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Jun 2017
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Efficacy, SelfStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wangen Li, MD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220919
- Sponsor's protocol ID
- weightbased
- Acronym
- WEB-IT
- Status last verified
- Jul 2017
- First submitted
- 8 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32933950
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03220919
- Acronym / sponsor ID
- WEB-IT / weightbased
- Conditions
- Efficacy, Self, Adverse Effect
- Keywords
- Insulin, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Weight-based | Experimental | Other: Weight-basedWeight-based insulin insulin titration regimen |
| Glucose level-based | Placebo comparator | Other: Glucose level-basedGlucose level-based insulin titration regimen |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 to 80 years with type 2 diabetes admitted to Endocrinology wards.
Key exclusion criteria (2 listed)
- Patients with hepatic or renal dysfunction, cancer, or diabetic ketoacidosis;
- Patients who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight-basedGlargine 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 | Other | Weight-based |
| Glucose level-basedGlargine 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. | Other | Glucose level-based |
Primary outcome
Duration
Time frame: at discharge, an average of 9 days
Duration to achieve BG targets, including three pre-meal BG and bedtime BG
Doses
Time frame: at discharge, an average of 9 days
Doses of insulin glargine and insulin aspart when the BG targets are achieved
1 secondary outcome
Hypoglycemia
Time frame: at discharge, an average of 9 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Derived from this study: PubMed 32933950Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wangen Li, MD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-based and Glucose level-based in people with Efficacy, Self and Adverse Effect, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaodan Zhang, MD (86-20-34152032, sysuzhangxd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration (time frame: at discharge, an average of 9 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03220919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.