Diabetes MellitusPhase 1/2NCT00353990
Bioavailability of Insulin Administered in Duodenum
A Phase 1/2 study testing Insulin Aspart in people with Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
Trial summary
A study of the bioavailability of insulin after infusion in the duodenum in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Insulin Aspart
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Dec 2006
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Healthy Volunteers
- Age >18 - < 50 years
- BMI 18-30 kg/m2
Who cannot join
- Any history of gastrointestinal or endocrine disorders (e.g. diabetes mellitus)
- pregnancy or nursing
- suspected or known allergy towards the drug
- Participation in other research trials within 3 months before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart Administered in the Duodenum in Healthy Volunteers - an Open Single Blinded and Uncontrolled Explorative Trial
A study of the bioavailability of insulin after infusion in the duodenum in healthy volunteers.
Read the detailed description
METHODOLOGY All subjects will be admitted fasting to the Clinical Trial Unit at Århus Community Hospital at 8 a.m. A Gastrointestinal tube will be placed in Duodenum distal to papilla Vaterii with a pH of approximately 7.0 as measured by the pH meter distal in the tube. An indwelling catheter for glucose infusion (20 %) in cases of hypoglycaemia will be placed in an antecubital vein. In the contralateral anticubital vein a catheter will be placed for blood sampling. All subjects will have 4 tests with duodenal infusion of the insulin Aspart solution. The first 4 volunteers will receive 4 doses of insulin Aspart solution in 1 ml (150, 300, 600 and 1000 IU) with 3-6 hours apart. Blood sampling for Insulin Aspart, total insulin, and glucose (Beckmann apparatus) will be done every 10 minutes the first two hours, and then every 20 minutes. When final the subjects will receive a meal before leaving the hospital.
Based on data from the pilot a dose will be determined for the remaining 8 subjects. These will then based again on results from the pilot on two separate study days receive 4 infusions with 3-6 hours split. Two infusions will be at pH 7 and two infusions will be more proximal at a pH of 5.5 (two different insulin concentrations but the same dose given at the two places in Duodenum). Frequency and interval of blood sampling in the second part will be determined by results from the pilot study. For comparison with the clinical situation and estimation of bioavailability all subjects will receive a subcutaneous and an intravenous (iv) bolus injection of 6 IU of insulin Aspart. The iv injection will be followed by blood sampling for three hours as above, but every 5 minutes the first two hours, and the sc injection will be followed by blood sampling for three hours as above, but again with 10 minutes interval the first two hours.
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin Aspart
- Keywords
- insulin, bioavailability, duodenum, infusion, healthy, diabetes, absorption
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin AspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the bioavailability of a solution of insulin Aspart infused in the Duodenum
Secondary outcomes (5)
Evaluate pharmacokinetics of insulin following duodenal administration
Evaluate intra- and intersubjects variation in pharmacokinetic
Evaluate pharmacodynamics of insulin
To assess any safety issues
Explore any influence of PH/ insulin concentration on PK /PD parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study startAug 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Investigators
- Torben Laursen, MD, DMSc, Ph.D., Principal investigator, Department of Clinical Pharmacology, Aarhus SygehusCharlotte A Ihlo, MD, Principal investigator, Department of Endocrinilogy, Universityhospital of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353990
- Sponsor's protocol ID
- 2006-002803-15
- Status last verified
- Apr 2007
- First submitted
- 18 Jul 2006
- Last updated
- 25 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability, Pharmacokinetics and Pharmacodynamics of Insulin Aspart Administered in the Duodenum in Healthy Volunteers - an Open Single Blinded and Uncontrolled Explorative Trial
- ClinicalTrials.gov ID
- NCT00353990
- Acronym / sponsor ID
- 2006-002803-15
- Conditions
- Diabetes Mellitus
- Keywords
- insulin, bioavailability, duodenum, infusion, healthy, diabetes, absorption
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Aug 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Jul 2006 (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.
A study of the bioavailability of insulin after infusion in the duodenum in healthy volunteers.
Detailed description
METHODOLOGY All subjects will be admitted fasting to the Clinical Trial Unit at Århus Community Hospital at 8 a.m. A Gastrointestinal tube will be placed in Duodenum distal to papilla Vaterii with a pH of approximately 7.0 as measured by the pH meter distal in the tube. An indwelling catheter for glucose infusion (20 %) in cases of hypoglycaemia will be placed in an antecubital vein. In the contralateral anticubital vein a catheter will be placed for blood sampling. All subjects will have 4 tests with duodenal infusion of the insulin Aspart solution. The first 4 volunteers will receive 4 doses of insulin Aspart solution in 1 ml (150, 300, 600 and 1000 IU) with 3-6 hours apart. Blood sampling for Insulin Aspart, total insulin, and glucose (Beckmann apparatus) will be done every 10 minutes the first two hours, and then every 20 minutes. When final the subjects will receive a meal before leaving the hospital.
Based on data from the pilot a dose will be determined for the remaining 8 subjects. These will then based again on results from the pilot on two separate study days receive 4 infusions with 3-6 hours split. Two infusions will be at pH 7 and two infusions will be more proximal at a pH of 5.5 (two different insulin concentrations but the same dose given at the two places in Duodenum). Frequency and interval of blood sampling in the second part will be determined by results from the pilot study. For comparison with the clinical situation and estimation of bioavailability all subjects will receive a subcutaneous and an intravenous (iv) bolus injection of 6 IU of insulin Aspart. The iv injection will be followed by blood sampling for three hours as above, but every 5 minutes the first two hours, and the sc injection will be followed by blood sampling for three hours as above, but again with 10 minutes interval the first two hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Healthy Volunteers
- Age >18 - < 50 years
- BMI 18-30 kg/m2
Key exclusion criteria (4 listed)
- Any history of gastrointestinal or endocrine disorders (e.g. diabetes mellitus)
- pregnancy or nursing
- suspected or known allergy towards the drug
- Participation in other research trials within 3 months before the study
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 | Drug | – |
Primary outcome
To define the bioavailability of a solution of insulin Aspart infused in the Duodenum
5 secondary outcomes
Evaluate pharmacokinetics of insulin following duodenal administration
Evaluate intra- and intersubjects variation in pharmacokinetic
Evaluate pharmacodynamics of insulin
To assess any safety issues
Explore any influence of PH/ insulin concentration on PK /PD parameters
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 25 Apr 2007.
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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.
Torben Laursen, MD, DMSc, Ph.D. principal investigator
Department of Clinical Pharmacology, Aarhus Sygehus
Charlotte A Ihlo, MD principal investigator
Department of Endocrinilogy, Universityhospital 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 1/2 study testing Insulin Aspart in people with 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 4 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 25 Apr 2007. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To define the bioavailability of a solution of insulin Aspart infused in the Duodenum. 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 25 Apr 2007.