Type 1 Diabetes MellitusPhase 4NCT00497536
Pharmacokinetics of IAsp Following CSII in Patients With T1DM
A Phase 4 study testing Insulin Aspart (IAsp) and Insulin Aspart (IAsp). in people with Type 1 Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour. The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin Aspart (IAsp) and Insulin Aspart (IAsp).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2007to Jul 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes mellitus (T1DM)
- Insulin pump users' ≥ 48 hours, 24 h dose < 80 U
- Insulin dose ≥ 0,4 IE/kg/24hours
- 18 years < age < 50 years
- Time since diagnosis of T1DM ≥ 5 years
- HbA1c ≤ 8,5 %
- Safe anticonceptive for fertile women
- Being able to understand and read Danish
Who cannot join
- Dysregulation of endocrine disorders other than type 1 diabetes mellitus
- Severe dysregulation of diabetes mellitus
- Other severe adverse disease
- Pregnancy, planning pregnancy, or nursing
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medicinsk Endokrinologisk Afdeling M
Aarhus C, Central Jutland, 8000
About this study
Official title: Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution.
The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour.
The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).
Read the detailed description
Rapid acting insulin, like insulin aspart, can be administered as CSII. The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes.
Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency. The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin Aspart (IAsp), Insulin Aspart (IAsp).
- Keywords
- Type 1 Diabetes Mellitus, Continuous Subcutaneous Insulin Infusion (CSII)
- 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 Aspart (IAsp)Drug
IAsp 100 U.
≈ bolus protocol: From 6 pm until 6 am
- 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm
1 dose/h + 50 % s.c. (≈ bolus).
Insulin Aspart (IAsp).Drug
IAsp 100 U From 6 pm until 8 am
- 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm 50 % increase of basal rate
Insulin Aspart (IAsp)Drug
IAsp 100 U From 6 pm until 8 am
- 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm 50 % increase of basal rate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ≈ bolus protocol. Receives: Drug: Insulin Aspart (IAsp) |
| 2 | Active comparator | ≈ CSII protocol Receives: Drug: Insulin Aspart (IAsp). |
| 3 | Active comparator | ≈ CIII protocol. Receives: Drug: Insulin Aspart (IAsp) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CV SSPIasp
Measured: 6 hours
Secondary outcomes (1)
• Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Torsten Lauritzen, MD, Study director, University of AarhusTorben Laursen, MD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497536
- Sponsor's protocol ID
- 2007-001912-21
- Status last verified
- Feb 2009
- First submitted
- 4 Jul 2007
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution.
- ClinicalTrials.gov ID
- NCT00497536
- Acronym / sponsor ID
- 2007-001912-21
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Continuous Subcutaneous Insulin Infusion (CSII)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Jul 2007 (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.
The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour.
The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).
Detailed description
Rapid acting insulin, like insulin aspart, can be administered as CSII. The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes.
Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency. The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Insulin Aspart (IAsp)≈ bolus protocol. |
| 2 | Active comparator | Drug: Insulin Aspart (IAsp).≈ CSII protocol |
| 3 | Active comparator | Drug: Insulin Aspart (IAsp)≈ CIII protocol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Type 1 diabetes mellitus (T1DM)
- Insulin pump users' ≥ 48 hours, 24 h dose < 80 U
- Insulin dose ≥ 0,4 IE/kg/24hours
- 18 years < age < 50 years
- Time since diagnosis of T1DM ≥ 5 years
Key exclusion criteria (4 listed)
- Dysregulation of endocrine disorders other than type 1 diabetes mellitus
- Severe dysregulation of diabetes mellitus
- Other severe adverse disease
- Pregnancy, planning pregnancy, or nursing
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 Aspart (IAsp)IAsp 100 U. ≈ bolus protocol: From 6 pm until 6 am • 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour) From 8 am until 6 pm 1 dose/h + 50 % s.c. (≈ bolus). | Drug | 1 |
| Insulin Aspart (IAsp).IAsp 100 U From 6 pm until 8 am • 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour) From 8 am until 6 pm 50 % increase of basal rate | Drug | 2 |
| Insulin Aspart (IAsp)IAsp 100 U From 6 pm until 8 am • 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour) From 8 am until 6 pm 50 % increase of basal rate | Drug | 3 |
Primary outcome
CV SSPIasp
Time frame: 6 hours
1 secondary outcome
• Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)
Time frame: 6 hours
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 5 Feb 2009.
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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.
Torsten Lauritzen, MD study director
University of Aarhus
Torben Laursen, MD study director
University of Aarhus
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 (IAsp) and Insulin Aspart (IAsp). in people with Type 1 Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
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 8 inclusion and 4 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 5 Feb 2009. 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 Denmark. 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?
CV SSPIasp (time frame: 6 hours). 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 5 Feb 2009.