DiabetesPhase 1NCT01520831
Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects
A Phase 1 study testing biphasic insulin aspart 30, biphasic insulin aspart 50 and biphasic insulin aspart 70 in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- What is being tested?
- biphasic insulin aspart 30, biphasic insulin aspart 50 and biphasic insulin aspart 70
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Apr 1999to May 2000
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index between 18 and 28 kg/m^2 inclusive
- HbA1c within the normal laboratory range
- 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
- Subjects who have received any investigational drug in the 3 months prior to the start of dosing
- Any disease requiring regular use of non topical prescription medicines
- Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
- Any intercurrent illness or endocrine disorders that may affect blood glucose
- Subject with a history of drug or alcohol dependence
- Subject with a first degree relative with diabetes mellitus
- Subject with a history of clinically relevant allergic reactions to medical products
- Subjects who have donated any blood or plasma in the past 3 month preceding screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart
This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.
- Being tested
- biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70, insulin aspart
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biphasic insulin aspart 30Drug
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
biphasic insulin aspart 50Drug
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
biphasic insulin aspart 70Drug
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
insulin aspartDrug
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 30 | Experimental | Not described Receives: Drug: biphasic insulin aspart 30 |
| BIAsp 50 | Experimental | Not described Receives: Drug: biphasic insulin aspart 50 |
| BIAsp 70 | Experimental | Not described Receives: Drug: biphasic insulin aspart 70 |
| Insulin aspart | Active comparator | Not described Receives: Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes
Secondary outcomes (7)
Maximum GIR value
Time to maximum GIR value
Area under the GIR profile
Cmax, maximum insulin aspart concentration
Area under the insulin aspart concentration curve
tmax, the time to maximum insulin aspart concentration
t½, terminal half-life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startApr 1999
- Primary completionMay 2000
- Study completionMay 2000
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520831
- Sponsor's protocol ID
- BIASP-1086
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2012
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Heise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart
- ClinicalTrials.gov ID
- NCT01520831
- Acronym / sponsor ID
- BIASP-1086
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- May 2000 (actual)
- Study completion
- May 2000 (actual)
- First posted
- 30 Jan 2012 (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.
This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIAsp 30 | Experimental | Drug: biphasic insulin aspart 30 |
| BIAsp 50 | Experimental | Drug: biphasic insulin aspart 50 |
| BIAsp 70 | Experimental | Drug: biphasic insulin aspart 70 |
| Insulin aspart | Active comparator | Drug: insulin aspart |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index between 18 and 28 kg/m^2 inclusive
- HbA1c within the normal laboratory range
- 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
Key exclusion criteria (8 listed)
- Subjects who have received any investigational drug in the 3 months prior to the start of dosing
- Any disease requiring regular use of non topical prescription medicines
- Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
- Any intercurrent illness or endocrine disorders that may affect blood glucose
- Subject with a history of drug or alcohol dependence
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 |
|---|---|---|
| biphasic insulin aspart 30One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days | Drug | BIAsp 30 |
| biphasic insulin aspart 50One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days | Drug | BIAsp 50 |
| biphasic insulin aspart 70One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days | Drug | BIAsp 70 |
| insulin aspartOne single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days | Drug | Insulin aspart |
Primary outcome
Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes
7 secondary outcomes
Maximum GIR value
Time to maximum GIR value
Area under the GIR profile
Cmax, maximum insulin aspart concentration
Area under the insulin aspart concentration curve
tmax, the time to maximum insulin aspart concentration
t½, terminal half-life
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 4 Jan 2017.
- Results publicationHeise T, Kapitza C, Jacobsen LV, Brøndsted L, Heinemann L. Pharmacokinetic and pharmacodynamic differences between premixed suspensions of insulin aspart: biphasic insulin aspart 30, 50 and 70. Diabetologia 2005; 48 (Suppl. 1): A301
- Clinical Trials at Novo NordiskLink 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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 biphasic insulin aspart 30, biphasic insulin aspart 50 and biphasic insulin aspart 70 in people with Diabetes and Healthy, run by Novo Nordisk A/S 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 4 inclusion and 8 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 4 Jan 2017. 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?
Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes. 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 NCT01520831, 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 4 Jan 2017.