Diabetes MellitusPhase 1NCT00513643
Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses
A Phase 1 study testing insulin aspart and human regular insulin in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- insulin aspart and human regular insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2002to Jun 2002
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent obtained before any trial-related activities
- Healthy subjects between 18 and 45 years inclusive
- Considered generally healthy upon completion of medical history and physical examination
- Body mass index (BMI) < 27 kg/m2
- HbA1c < 6,1 %
- Non-smoker for at least three months
- Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD), the oral contraceptive pill or barrier methods.
Who cannot join
- Participation in any other clinical trial and receipt of any investigational drug within four weeks prior to this trial
- Previous participation in this trial
- Clinically significant abnormal haematology or biochemistry screening test
- Any disease requiring use of non topical prescription medicines
- Any serious systemic infectious disease that occurred in the four weeks prior to the first dose of test drug
- Any intercurrent illness that may affect blood glucose
Show all 11Show fewer
- Current addiction to alcohol or substances of abuse as determined by the investigator
- Known or suspected allergy against insulin or any component of the composition of the trial drug
- Blood donation > 500 ml within the last nine weeks
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- If female, subject is pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacodynamic and Pharmacokinetic Properties of Insulin Aspart: Dose - Ranging vs. Human Soluble Insulin
The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.
Read the detailed description
Double-blind, randomized, 6-period cross-over study in 16 healthy subjects. Each patient participates in 6 euglycemic glucose clamp experiments each.
The time interval between the study days is 2 to 28 days. At the clamp visits, subjects are connected to a Biostator (MTB Medizintechnik, Ulm, Germany) and receive an intravenous human insulin infusion (rate of 0.15 mU/kg/min) over the duration of each experiment to prevent a rise in endogenous insulin secretion. After a baseline period of 2 h the trial drug (6, 12, or 24 U of either Insulin Aspart or regular human insulin in random order) are administered s.c. with a syringe into the abdominal wall. Glucose infusion rates (GIR) necessary to keep blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered and recorded by the Biostator every minute for a period of 12 h post-dosing. Blood samples are drawn at regular intervals for the analysis of C-peptide and (depending on the trial drug administered) serum insulin or serum Insulin Aspart concentrations (measured with specific ELISAs).
- Conditions
- Diabetes Mellitus
- Being tested
- insulin aspart, human regular insulin
- Keywords
- euglycaemic glucose clamp, duration of action, late metabolic activity, hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspartDrug
Also called Novorapid
6, 12, 24 U s.c.
human regular insulinDrug
Also called Actrapid
6, 12 and 24 IU sc
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 6 U insulin aspart Receives: Drug: insulin aspart |
| 2 | Experimental | 12 U insulin aspart Receives: Drug: insulin aspart |
| 3 | Experimental | 24 U insulin aspart Receives: Drug: insulin aspart |
| 4 | Active comparator | 6 IU human regular insulin Receives: Drug: human regular insulin |
| 5 | Active comparator | 12 IU human regular insulin Receives: Drug: human regular insulin |
| 6 | Active comparator | 24 IU human regular insulin Receives: Drug: human regular insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC GIR 360-720 min
Measured: at each dosing (6 times during the trial)
Secondary outcomes (2)
PK endpoints such as C max/ins, t max/ins, AUC ins 0-120 min, AUC ins 360-720 min, AUC ins 0-720 min
Measured: at each dosing visit (6 times during the study)
PD endpoints like GIR max, t max/GIR, AUC GIR 0-120 min, AUC GIR 0-720 min, t >2/GIR, early and late t 50%/GIR
Measured: at each dosing visit (6 times during the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startApr 2002
- Study completionJun 2002
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S
- Investigators
- Tim Heise, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513643
- Sponsor's protocol ID
- ISPS_Dose-ranging
- Status last verified
- Aug 2007
- First submitted
- 8 Aug 2007
- Last updated
- 9 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic and Pharmacokinetic Properties of Insulin Aspart: Dose - Ranging vs. Human Soluble Insulin
- ClinicalTrials.gov ID
- NCT00513643
- Acronym / sponsor ID
- ISPS_Dose-ranging
- Conditions
- Diabetes Mellitus
- Keywords
- euglycaemic glucose clamp, duration of action, late metabolic activity, hypoglycaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S
- Study start
- Apr 2002
- Study completion
- Jun 2002 (actual)
- First posted
- 9 Aug 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 metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.
Detailed description
Double-blind, randomized, 6-period cross-over study in 16 healthy subjects. Each patient participates in 6 euglycemic glucose clamp experiments each.
The time interval between the study days is 2 to 28 days. At the clamp visits, subjects are connected to a Biostator (MTB Medizintechnik, Ulm, Germany) and receive an intravenous human insulin infusion (rate of 0.15 mU/kg/min) over the duration of each experiment to prevent a rise in endogenous insulin secretion. After a baseline period of 2 h the trial drug (6, 12, or 24 U of either Insulin Aspart or regular human insulin in random order) are administered s.c. with a syringe into the abdominal wall. Glucose infusion rates (GIR) necessary to keep blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered and recorded by the Biostator every minute for a period of 12 h post-dosing. Blood samples are drawn at regular intervals for the analysis of C-peptide and (depending on the trial drug administered) serum insulin or serum Insulin Aspart concentrations (measured with specific ELISAs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: insulin aspart6 U insulin aspart |
| 2 | Experimental | Drug: insulin aspart12 U insulin aspart |
| 3 | Experimental | Drug: insulin aspart24 U insulin aspart |
| 4 | Active comparator | Drug: human regular insulin6 IU human regular insulin |
| 5 | Active comparator | Drug: human regular insulin12 IU human regular insulin |
| 6 | Active comparator | Drug: human regular insulin24 IU human regular insulin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent obtained before any trial-related activities
- Healthy subjects between 18 and 45 years inclusive
- Considered generally healthy upon completion of medical history and physical examination
- Body mass index (BMI) < 27 kg/m2
- HbA1c < 6,1 %
Key exclusion criteria (11 listed)
- Participation in any other clinical trial and receipt of any investigational drug within four weeks prior to this trial
- Previous participation in this trial
- Clinically significant abnormal haematology or biochemistry screening test
- Any disease requiring use of non topical prescription medicines
- Any serious systemic infectious disease that occurred in the four weeks prior to the first dose of test drug
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: Novorapid6, 12, 24 U s.c. | Drug | 1, 2, 3 |
| human regular insulinAlso: Actrapid6, 12 and 24 IU sc | Drug | 4, 5, 6 |
Primary outcome
AUC GIR 360-720 min
Time frame: at each dosing (6 times during the trial)
2 secondary outcomes
PK endpoints such as C max/ins, t max/ins, AUC ins 0-120 min, AUC ins 360-720 min, AUC ins 0-720 min
Time frame: at each dosing visit (6 times during the study)
PD endpoints like GIR max, t max/GIR, AUC GIR 0-120 min, AUC GIR 0-720 min, t >2/GIR, early and late t 50%/GIR
Time frame: at each dosing visit (6 times during the study)
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 9 Aug 2007.
- Profil Institut für StoffwechselforschungLink provided by the sponsor.
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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.
Tim Heise, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing insulin aspart and human regular insulin in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
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 7 inclusion and 11 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 9 Aug 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 Germany. 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 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.
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?
AUC GIR 360-720 min (time frame: at each dosing (6 times during the trial)). 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 9 Aug 2007.