DiabetesPhase 1NCT01527565
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
A Phase 1 study testing biphasic insulin aspart 70 in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in South Africa.
Trial summary
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- What is being tested?
- biphasic insulin aspart 70
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- 20 Jan 2003to 26 Feb 2003
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Considered generally healthy upon completion of medical history and physical
- examination, as judged by the investigator
- Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
- Minimum body weight of 65 kg
- Fasting blood glucose between 3.8-6.0 mmol/L
- Glycohemoglobin (HbA1c) below 6.4 %
- Non-smokers
Who cannot join
- Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
- A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
- History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
- Hepatitis B or C
- Subjects with a first-degree relative with diabetes mellitus
- Known or suspected allergy to trial product or related products
- Smoking during the past three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.
- Being tested
- biphasic insulin aspart 70
- 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 70Drug
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | Not described Receives: Drug: biphasic insulin aspart 70 |
| Formulation B | Experimental | Not described Receives: Drug: biphasic insulin aspart 70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration
Secondary outcomes (7)
tmax, the time to maximum insulin aspart concentration
Area under the insulin aspart curve
Mean residence time (MRT)
The area under the glucose infusion rate curve
GIRmax, maximum glucose infusion rate value
tGIRmax, time to maximum glucose infusion rate value
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study start20 Jan 2003
- Primary completion26 Feb 2003
- Study completion26 Feb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 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
- NCT01527565
- Sponsor's protocol ID
- BIASP-1489
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2012
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01527565
- Acronym / sponsor ID
- BIASP-1489
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2003 (actual)
- Primary completion
- 26 Feb 2003 (actual)
- Study completion
- 26 Feb 2003 (actual)
- First posted
- 7 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 Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: biphasic insulin aspart 70 |
| Formulation B | Experimental | Drug: biphasic insulin aspart 70 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Considered generally healthy upon completion of medical history and physical
- examination, as judged by the investigator
- Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
- Minimum body weight of 65 kg
- Fasting blood glucose between 3.8-6.0 mmol/L
Key exclusion criteria (7 listed)
- Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
- A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
- History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
- Hepatitis B or C
- Subjects with a first-degree relative with diabetes mellitus
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 70A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days | Drug | Formulation A, Formulation B |
Primary outcome
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration
7 secondary outcomes
tmax, the time to maximum insulin aspart concentration
Area under the insulin aspart curve
Mean residence time (MRT)
The area under the glucose infusion rate curve
GIRmax, maximum glucose infusion rate value
tGIRmax, time to maximum glucose infusion rate value
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 24 Feb 2017.
- 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 70 in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in South Africa.
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 7 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 24 Feb 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 South Africa. 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 insulin aspart curve in the interval from 0-16 hours. The study lists 2 primary outcomes in all. 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 24 Feb 2017.