Type 1 Diabetes MellitusPhase 4NCT00461331
Comparison of Insulins Aspart and Lispro in Insulin Pumps
A Phase 4 study testing Insulin Aspart and Insulin Lispro in people with Type 1 Diabetes Mellitus, run by Tulane University Health Sciences Center at 1 site in United States.
Trial summary
The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin Aspart and Insulin Lispro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 Diabetes treated with a pump for at least 3 months
Who cannot join
- Pregnancy
- Plasma Creatinine > 1.2 mg/dl
- Inability to give informed consent
- HbA1c > 8%
- Known or suspected hypersensitivity to trial drugs or any of their components
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Translational Unit - Tulane School of Medicine
New Orleans, Louisiana, 70112
About this study
Official title: A Comparison of the Efficacy Beyond 48 Hours of Insulin Aspart (Novolog) and Lispro (Humalog) in Insulin Pumps
The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.
Read the detailed description
Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has been disappointing. The recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations.
One of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. However, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. In addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. The development of continuous glucose monitoring system (CGMS) and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines.
The different variables will be compared between the two insulins using a paired t test.
- Glycemic control will be will be compared 24 to 100 hours after pump infusion line change using CGMS and daily serum 1,5-anhydroglucitol.
- Post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared.
- The used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control.
- Comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin Aspart, Insulin Lispro
- Keywords
- Type 1 diabetes mellitus, Glycemic control, Continuous subcutaneous insulin infusion, Continuous glucose monitoring system
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin AspartDrug
Also called Insulin lispro - insulin Humalog, Insulin aspart - insulin Novolog
Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study.
Insulin LisproDrug
Also called Insulin Aspart
Patients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2.
| Study group | Role | What they receive |
|---|---|---|
| Insulin 1 | Active comparator | Either insulin Aspart or insulin Lispro were randomized to be insulin 1. Receives: Drug: Insulin Aspart |
| Insulin 2 | Active comparator | Between insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study. Receives: Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change
For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level >300 mg/dL.
Measured: 24 to 100 hours after last pump infusion line change
Secondary outcomes (2)
Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place
Daily serum glycomark levels between day 3 and day 5 after the pump infusion line change. These levels were measured for both the test periods.
Measured: 48 to 100 hours after keeping the same pump infusion line in place
Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place
Free 15-F2t isoprostane was measured between days 3 and 5 after the keeping the same pump infusion line in place. It is a marker of oxidative stress due to hyperglycemia that was being compared between the two test periods.
Measured: Between 48, 72 and 96 hours after the last pump infusion line change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startOct 2004
- Primary completionJun 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian A Fonseca, MD, FRCP, Principal investigator, Tulane Universtiy Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461331
- Sponsor's protocol ID
- F-0215
- Status last verified
- Jan 2021
- First submitted
- 16 Apr 2007
- Last updated
- 8 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy Beyond 48 Hours of Insulin Aspart (Novolog) and Lispro (Humalog) in Insulin Pumps
- ClinicalTrials.gov ID
- NCT00461331
- Acronym / sponsor ID
- F-0215
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, Glycemic control, Continuous subcutaneous insulin infusion, Continuous glucose monitoring system
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tulane University Health Sciences CenterUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Posted 19 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump.
Detailed description
Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has been disappointing. The recommended duration of "needle use" in insulin pump treatment is 48 hours, based on anecdotal observations.
One of the reasons for the suboptimal control may be that patients do not adhere to the advice of changing their pump infusion line every 48 hours. However, it is possible that the loss of glycemic control may be related to instability of insulin in the pump/line. In addition to premeal loss of control after 48 hours of line change, very little is known about post-prandial hyperglycemia leading to loss of efficacy of the insulin via an insulin pump bolus. The development of continuous glucose monitoring system (CGMS) and new tests for short term fluctuations in glucose control such as 1,5-anhydroglucitol make it easier to evaluate the impact of short term loss of control in patients using the insulin pump who delay changing their lines.
The different variables will be compared between the two insulins using a paired t test.
- Glycemic control will be will be compared 24 to 100 hours after pump infusion line change using CGMS and daily serum 1,5-anhydroglucitol.
- Post prandial glycemic excursions in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a pump infusion line change will be compared.
- The used pump infusion line will be collected from the patient and analyzed for insulin binding to the plastic, as well as other possible effects that may determine its role in loss of glycemic control.
- Comparison of some of the markers of coagulation, inflammation, protein glycation and oxidative stress 48, 72, and 96 hours after a pump infusion line change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin 1 | Active comparator | Drug: Insulin AspartEither insulin Aspart or insulin Lispro were randomized to be insulin 1. |
| Insulin 2 | Active comparator | Drug: Insulin LisproBetween insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 1 Diabetes treated with a pump for at least 3 months
Key exclusion criteria (5 listed)
- Pregnancy
- Plasma Creatinine > 1.2 mg/dl
- Inability to give informed consent
- HbA1c > 8%
- Known or suspected hypersensitivity to trial drugs or any of their components
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 |
|---|---|---|
| Insulin AspartAlso: Insulin lispro - insulin Humalog, Insulin aspart - insulin NovologEither one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study. | Drug | Insulin 1 |
| Insulin LisproAlso: Insulin AspartPatients were given either insulin Aspart or Lispro in test period 1. Then they were switched to the other insulin in test period 2. | Drug | Insulin 2 |
Primary outcome
Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change
Time frame: 24 to 100 hours after last pump infusion line change
For each test period, we measured the duration of time that the same pump infusion line could be kept in place without losing glycemic control. Loss of glycemic control was defined as capillary blood glucose level >300 mg/dL.
2 secondary outcomes
Daily Serum Glycomark Levels 48 to 100 Hours After Keeping the Same Pump Infusion Line in Place
Time frame: 48 to 100 hours after keeping the same pump infusion line in place
Oxidative Stress Marker 48, 72 and 96 Hours After Keeping the Same Pump Infusion Line in Place
Time frame: Between 48, 72 and 96 hours after the last pump infusion line change
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vivian A Fonseca, MD, FRCP principal investigator
Tulane Universtiy Health Sciences Center
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 Insulin Aspart and Insulin Lispro in people with Type 1 Diabetes Mellitus, run by Tulane University Health Sciences Center at 1 site in United States.
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 5 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 8 Jan 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Glycemic Control (Glucose Levels Between 180-300 mg/dL) 24 to 100 Hours After Line Change (time frame: 24 to 100 hours after last pump infusion line change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2021.