DiabetesPhase 1NCT01526941
Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes
A Phase 1 study testing biphasic insulin aspart 30 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 single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- biphasic insulin aspart 30 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
- 27 participants
- Where
- 1 siteGermany
- Study dates
- May 2001to Jul 2001
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes for at least 12 months
- Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
- BMI (Body Mass Index) maximum 35 kg/m^2
- Able and willing to perform self-blood glucose monitoring
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
- Currently being treated with insulin aspart products
- A history of drug abuse or alcohol dependence within the last 5 years
- Impaired hepatic function
- Impaired renal function
Show all 9Show fewer
- Blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
- Cardiac problems
- Severe, uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Two-Period Crossover Trial Comparing the Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- biphasic insulin aspart 30, biphasic insulin aspart 70
- 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
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
biphasic insulin aspart 70Drug
Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
| Study group | Role | What they receive |
|---|---|---|
| Treatment period 1 | Experimental | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 70 |
| Treatment period 2 | Experimental | Not described Receives: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state area under the glucose infusion rate profile, 6-12 hours
Secondary outcomes (9)
GIRmax, the maximal glucose infusion rate value
tmax, time to maximum glucose infusion rate value
area under the glucose infusion rate profile
Time to 50% of area under the glucose infusion rate profile, 0-12 hours
Cmax, maximum concentration
tmax, time to reach Cmax
Area under the curve
t½, terminal half-life
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startMay 2001
- Primary completionJul 2001
- Study completionJul 2001
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
- 27 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
- NCT01526941
- Sponsor's protocol ID
- BIASP-1318
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2012
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin Aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin Aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):545-50. doi: 10.1055/s-2005-872852.
PubMed 16235159
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Two-Period Crossover Trial Comparing the Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Insulin Aspart 70 in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01526941
- Acronym / sponsor ID
- BIASP-1318
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 6 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 single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment period 1 | Experimental | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 70 |
| Treatment period 2 | Experimental | Drug: biphasic insulin aspart 30, Drug: biphasic insulin aspart 70 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 diabetes for at least 12 months
- Currently on basal bolus treatment with soluble human insulin, Lispro and NPH insulin or Lantus. NPH insulin may be administered once or twice daily
- BMI (Body Mass Index) maximum 35 kg/m^2
- Able and willing to perform self-blood glucose monitoring
Key exclusion criteria (9 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
- Currently being treated with insulin aspart products
- A history of drug abuse or alcohol dependence 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 30Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods | Drug | Treatment period 1, Treatment period 2 |
| biphasic insulin aspart 70Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods | Drug | Treatment period 1, Treatment period 2 |
Primary outcome
Steady state area under the glucose infusion rate profile, 6-12 hours
9 secondary outcomes
GIRmax, the maximal glucose infusion rate value
tmax, time to maximum glucose infusion rate value
area under the glucose infusion rate profile
Time to 50% of area under the glucose infusion rate profile, 0-12 hours
Cmax, maximum concentration
tmax, time to reach Cmax
Area under the curve
t½, terminal half-life
Adverse events
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 Jan 2017.
- Results publication: PubMed 16235159Bott S, Tusek C, Heinemann L, Friberg HH, Heise T. The pharmacokinetic and pharmacodynamic properties of biphasic insulin Aspart 70 (BIAsp 70) are significantly different from those of biphasic insulin Aspart 30 (BIAsp 30). Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):545-50. doi: 10.1055/s-2005-872852.
- 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 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 4 inclusion and 9 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 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?
Steady state area under the glucose infusion rate profile, 6-12 hours. 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 NCT01526941, 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 5 Jan 2017.