HyperglycemiaPhase 4NCT02165566
Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit
A Phase 4 study testing Regular-insulin and Lispro-insulin in people with Hyperglycemia, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Insulin preparation -random assignment to regular insulin lin or lispro insulin as first treatment- was administered at constant infusion rate (0.04 units/Kg/h) in patients presenting blood glucose concentration ≥180 mg/dl and was discontinued when blood glucose concentration ≤140 mg/dl (therapeutic blood glucose… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Regular-insulin and Lispro-insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to May 2014
- Phase
- Phase 4
- 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
- critical care patients with blood glucose concentration >180mg/dl
Who cannot join
- insulin dependent diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Insulin preparation -random assignment to regular insulin lin or lispro insulin as first treatment- was administered at constant infusion rate (0.04 units/Kg/h) in patients presenting blood glucose concentration ≥180 mg/dl and was discontinued when blood glucose concentration ≤140 mg/dl (therapeutic blood glucose concentration drop). Further reduction in blood glucose concentration after discontinuation of insulin infusion was recorded (post-infusional blood glucose concentration drop). During the study period blood glucose concentration, in whole blood, was measured every 30 minutes. At least 6 hours interval was allowed between the 2 treatments.
Read the detailed description
Inclusion criteria: Patients older than 18 years of age receiving full nutritional calories supply who presented blood glucose concentration ≥180 mg/dl. Exclusion criteria: moribund patients and patients enrolled on other studies were excluded. Patients with type 1 diabetes, patients with insulin-dependent diabetes are excluded and patients with glycated hemoglobin (glycosilated hemoglobin) >5.6% are also excluded because of the potential of underlying insulin resistance.
A randomized crossover design is used. Patients receiving insulin infusion therapy are prospectively enrolled and randomly assigned to start the treatment either with lispro insulin or regular insulin at a dose of 0.04 units/Kg/h. After full enteral or parenteral nutrition is established, the insulin infusion therapy is started if blood glucose concentration ≥180 mg/dl (upper blood glucose concentration threshold) and is kept constant until blood glucose concentration is ≤140 mg/dl (lower blood glucose concentration threshold). Insulin infusion is discontinued after the blood glucose concentration reached ≤140 mg/dl. Because of the crossover design of the study, the same patient is treated with both lispro insulin or regular insulin infusion allowing an interval of at least 6 hours between the 2 treatments. During the study period -IIT and after insulin infusion is discontinued- the blood glucose concentration is measured every 30 minutes in whole blood (with blood gas analysis) until blood glucose concentration values return within the target threshold (140-180 mg/dl). The primary outcome measure was the extent of "residual effect" after that insulin (Hlog or Hlin) infusion has been discontinued. This variable is expressed as the ratio between blood glucose concentration reduction during insulin infusion (from the beginning of insulin infusion for blood glucose concentration values >180 mg/dl, to the first measurement ≤140 mg/dl) and blood glucose concentration reduction after insulin infusion is discontinued (from the first blood glucose concentration value ≤140 mg/dl to the lowest blood glucose concentration value recorded). Secondary end point measures are: rate of blood glucose concentration reduction during insulin infusion (mg/dl/h-1), duration of the "residual effect" (time elapsed between insulin infusion discontinuation and the lowestblood glucose concentration value), and the rate of blood glucose concentration increase from lowest blood glucose concentration value to the first blood glucose concentration value ≥140 mg/dl.
- Conditions
- Hyperglycemia
- Being tested
- Regular-insulin, Lispro-insulin
- Keywords
- intensive insulin therapy, critical care patients, blood glucose concentration>180 mg/dl
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular-insulinDrug
Also called Humulin
patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion
Lispro-insulinDrug
Also called Humalog
patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion
| Study group | Role | What they receive |
|---|---|---|
| Regular-insulin, | Experimental | regular-insulin or lispro-insulin at 0.04 units/kg/hour continuous infusion crossover and random assignement Receives: Drug: Regular-insulin |
| Lispro insulin | Experimental | patients randomly assigned in a crossover way to one of the 2 treatments Receives: Drug: Lispro-insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of insulin residual effect in critical care patients
the ratio between the therapeutic effect and the glycemia reduction after insulin is discontinued
Measured: patients will be followed during insulin infusion in a time frame of minutes/hours, with an expected average time of 6-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionMay 2014
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 HyperglycemiaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Bilotta, University of Roma La Sapienza
- Investigators
- Federico Bilotta, MD, PhD, Principal investigator, Department of Anesthesiology, University of ROme "La Sapienza"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165566
- Sponsor's protocol ID
- HlogHlin
- Status last verified
- Jun 2014
- First submitted
- 7 May 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bilotta F, Badenes R, Lolli S, Belda FJ, Einav S, Rosa G. Insulin infusion therapy in critical care patients: regular insulin vs short-acting insulin. A prospective, crossover, randomized, multicenter blind study. J Crit Care. 2015 Apr;30(2):437.e1-6. doi: 10.1016/j.jcrc.2014.10.019. Epub 2014 Oct 30.
PubMed 25466315
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humalog or Humulin for Intensive Insulin Therapy in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02165566
- Acronym / sponsor ID
- HlogHlin
- Conditions
- Hyperglycemia
- Keywords
- intensive insulin therapy, critical care patients, blood glucose concentration>180 mg/dl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Jun 2014 (estimated)
- 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.
Insulin preparation -random assignment to regular insulin lin or lispro insulin as first treatment- was administered at constant infusion rate (0.04 units/Kg/h) in patients presenting blood glucose concentration ≥180 mg/dl and was discontinued when blood glucose concentration ≤140 mg/dl (therapeutic blood glucose concentration drop). Further reduction in blood glucose concentration after discontinuation of insulin infusion was recorded (post-infusional blood glucose concentration drop). During the study period blood glucose concentration, in whole blood, was measured every 30 minutes. At least 6 hours interval was allowed between the 2 treatments.
Detailed description
Inclusion criteria: Patients older than 18 years of age receiving full nutritional calories supply who presented blood glucose concentration ≥180 mg/dl. Exclusion criteria: moribund patients and patients enrolled on other studies were excluded. Patients with type 1 diabetes, patients with insulin-dependent diabetes are excluded and patients with glycated hemoglobin (glycosilated hemoglobin) >5.6% are also excluded because of the potential of underlying insulin resistance.
A randomized crossover design is used. Patients receiving insulin infusion therapy are prospectively enrolled and randomly assigned to start the treatment either with lispro insulin or regular insulin at a dose of 0.04 units/Kg/h. After full enteral or parenteral nutrition is established, the insulin infusion therapy is started if blood glucose concentration ≥180 mg/dl (upper blood glucose concentration threshold) and is kept constant until blood glucose concentration is ≤140 mg/dl (lower blood glucose concentration threshold). Insulin infusion is discontinued after the blood glucose concentration reached ≤140 mg/dl. Because of the crossover design of the study, the same patient is treated with both lispro insulin or regular insulin infusion allowing an interval of at least 6 hours between the 2 treatments. During the study period -IIT and after insulin infusion is discontinued- the blood glucose concentration is measured every 30 minutes in whole blood (with blood gas analysis) until blood glucose concentration values return within the target threshold (140-180 mg/dl). The primary outcome measure was the extent of "residual effect" after that insulin (Hlog or Hlin) infusion has been discontinued. This variable is expressed as the ratio between blood glucose concentration reduction during insulin infusion (from the beginning of insulin infusion for blood glucose concentration values >180 mg/dl, to the first measurement ≤140 mg/dl) and blood glucose concentration reduction after insulin infusion is discontinued (from the first blood glucose concentration value ≤140 mg/dl to the lowest blood glucose concentration value recorded). Secondary end point measures are: rate of blood glucose concentration reduction during insulin infusion (mg/dl/h-1), duration of the "residual effect" (time elapsed between insulin infusion discontinuation and the lowestblood glucose concentration value), and the rate of blood glucose concentration increase from lowest blood glucose concentration value to the first blood glucose concentration value ≥140 mg/dl.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular-insulin, | Experimental | Drug: Regular-insulinregular-insulin or lispro-insulin at 0.04 units/kg/hour continuous infusion crossover and random assignement |
| Lispro insulin | Experimental | Drug: Lispro-insulinpatients randomly assigned in a crossover way to one of the 2 treatments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- critical care patients with blood glucose concentration >180mg/dl
Key exclusion criteria (1 listed)
- insulin dependent diabetes
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 |
|---|---|---|
| Regular-insulinAlso: Humulinpatients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion | Drug | Regular-insulin, |
| Lispro-insulinAlso: Humalogpatients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion | Drug | Lispro insulin |
Primary outcome
Extent of insulin residual effect in critical care patients
Time frame: patients will be followed during insulin infusion in a time frame of minutes/hours, with an expected average time of 6-8 hours
the ratio between the therapeutic effect and the glycemia reduction after insulin is discontinued
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Derived from this study: PubMed 25466315Bilotta F, Badenes R, Lolli S, Belda FJ, Einav S, Rosa G. Insulin infusion therapy in critical care patients: regular insulin vs short-acting insulin. A prospective, crossover, randomized, multicenter blind study. J Crit Care. 2015 Apr;30(2):437.e1-6. doi: 10.1016/j.jcrc.2014.10.019. Epub 2014 Oct 30.
Related trials for Hyperglycemia
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
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.
Federico Bilotta, MD, PhD principal investigator
Department of Anesthesiology, University of ROme "La Sapienza"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Regular-insulin and Lispro-insulin in people with Hyperglycemia, run by University of Roma La Sapienza at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 17 Jun 2014. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of insulin residual effect in critical care patients (time frame: patients will be followed during insulin infusion in a time frame of minutes/hours, with an expected average time of 6-8 hours). 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 NCT02165566, 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 17 Jun 2014.