DiabetesPhase 1NCT01536028
Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes
A Phase 1 study testing biphasic insulin aspart 30, biphasic insulin aspart 50 and biphasic insulin aspart 70 in people with Diabetes and Diabetes Mellitus, Type 1, 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 compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- 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
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2006to Jul 2006
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes for at least 12 months
- Serum C-peptide maximum 0.4 ng/mL
- Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
- BMI (Body Mass Index) maximum 32 kg/m^2
- HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
- Non-smoker
Who cannot join
- The receipt of any investigational drug within the last 30 days prior to this trial
- Total daily insulin dose at least 1.8 U/kg/day
- Current treatment with IAsp (insulin aspart) products
- A history of drug or alcohol abuse within the last 5 years
- Impaired hepatic function
- Impaired renal function
- Cardiac problems
- Severe, uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biphasic insulin aspart 30Drug
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 50Drug
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
biphasic insulin aspart 70Drug
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
insulin aspartDrug
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
| Study group | Role | What they receive |
|---|---|---|
| BIAsp 30 | Active comparator | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70; Drug: insulin aspart |
| BIAsp 50 | Experimental | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70; Drug: insulin aspart |
| BIAsp 70 | Experimental | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70; Drug: insulin aspart |
| IAsp | Active comparator | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70; 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)-curves in the first two hours post-dosing
Secondary outcomes (11)
Maximum GIR value
Time to maximum GIR value
Area under the GIR-curves
Maximum drug concentration for insulin aspart (IAsp)
Time to maximum IAsp concentration
Area under the curve of the IAsp profiles
Minimum drug concentration in NEFA (Nonesterified fatty acids)
Time to minimum plasma concentration, NEFA
Area under the curve of the NEFA profiles
Adverse events
Hypoglycaemic episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startApr 2006
- Primary completionJul 2006
- Study completionJul 2006
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
- 32 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
- NCT01536028
- Sponsor's protocol ID
- BIASP-1746
- Other IDs
- 2005-004965-40, 2005
- Status last verified
- Jan 2017
- First submitted
- 15 Feb 2012
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.1089/dia.2008.0019.
PubMed 19049377
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01536028
- Acronym / sponsor ID
- BIASP-1746
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 20 Feb 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 compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIAsp 30 | Active comparator | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 50, Drug: biphasic insulin aspart 70, Drug: insulin aspart |
| BIAsp 50 | Experimental | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 50, Drug: biphasic insulin aspart 70, Drug: insulin aspart |
| BIAsp 70 | Experimental | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 50, Drug: biphasic insulin aspart 70, Drug: insulin aspart |
| IAsp | Active comparator | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 50, Drug: biphasic insulin aspart 70, Drug: insulin aspart |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Type 1 diabetes for at least 12 months
- Serum C-peptide maximum 0.4 ng/mL
- Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
- BMI (Body Mass Index) maximum 32 kg/m^2
- HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
Key exclusion criteria (8 listed)
- The receipt of any investigational drug within the last 30 days prior to this trial
- Total daily insulin dose at least 1.8 U/kg/day
- Current treatment with IAsp (insulin aspart) products
- A history of drug or alcohol abuse within the last 5 years
- Impaired hepatic function
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 30A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between | Drug | BIAsp 30, BIAsp 50, BIAsp 70, IAsp |
| biphasic insulin aspart 50A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between | Drug | BIAsp 30, BIAsp 50, BIAsp 70, IAsp |
| biphasic insulin aspart 70A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between | Drug | BIAsp 30, BIAsp 50, BIAsp 70, IAsp |
| insulin aspartA single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between | Drug | BIAsp 30, BIAsp 50, BIAsp 70, IAsp |
Primary outcome
Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
11 secondary outcomes
Maximum GIR value
Time to maximum GIR value
Area under the GIR-curves
Maximum drug concentration for insulin aspart (IAsp)
Time to maximum IAsp concentration
Area under the curve of the IAsp profiles
Minimum drug concentration in NEFA (Nonesterified fatty acids)
Time to minimum plasma concentration, NEFA
Area under the curve of the NEFA profiles
Adverse events
Hypoglycaemic episodes
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 6 Jan 2017.
- Results publication: PubMed 19049377Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther. 2008 Dec;10(6):479-85. doi: 10.1089/dia.2008.0019.
- 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 Diabetes Mellitus, Type 1, 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 6 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 6 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)-curves in the first two hours post-dosing. 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 NCT01536028, 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 6 Jan 2017.