DiabetesPhase 1NCT01698697
Comparison of Two Insulin Aspart Formulations in Healthy Volunteers
A Phase 1 study testing insulin aspart 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 determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- What is being tested?
- insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Africa
- Study dates
- 2 Sep 2002to 18 Oct 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
- Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
- Weight 60-90 kg
- Non-smoker
Who cannot join
- Any condition requiring the regular use of any medication
- Known or suspected allergy to the trial product or related products
- Family history of type 1 diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers
This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).
- Being tested
- 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.
insulin aspartDrug
Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion
| Study group | Role | What they receive |
|---|---|---|
| U100 | Active comparator | Not described Receives: Drug: insulin aspart |
| U200 | Experimental | 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 curve (AUC)
Area under the glucose infusion rate curve
Secondary outcomes (6)
Cmax (maximum plasma concentration)
Time to reach maximum (tmax)
Terminal half-life (t½)
Incidence of hypoglycemic events
Adverse events
GIRmax: The maximal GIR (glucose infusion rate)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study start2 Sep 2002
- Primary completion18 Oct 2002
- Study completion18 Oct 2002
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
- 24 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
- NCT01698697
- Sponsor's protocol ID
- NN248-1494
- Status last verified
- Feb 2017
- First submitted
- 28 Sep 2012
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01698697
- Acronym / sponsor ID
- NN248-1494
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2002 (actual)
- Primary completion
- 18 Oct 2002 (actual)
- Study completion
- 18 Oct 2002 (actual)
- First posted
- 3 Oct 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 determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U100 | Active comparator | Drug: insulin aspart |
| U200 | Experimental | Drug: insulin aspart |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
- Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
- Weight 60-90 kg
- Non-smoker
Key exclusion criteria (3 listed)
- Any condition requiring the regular use of any medication
- Known or suspected allergy to the trial product or related products
- Family history of type 1 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 |
|---|---|---|
| insulin aspartBolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion | Drug | U100, U200 |
Primary outcome
Area under the curve (AUC)
Area under the glucose infusion rate curve
6 secondary outcomes
Cmax (maximum plasma concentration)
Time to reach maximum (tmax)
Terminal half-life (t½)
Incidence of hypoglycemic events
Adverse events
GIRmax: The maximal GIR (glucose infusion rate)
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 1 Mar 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 insulin aspart 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 5 inclusion and 3 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 1 Mar 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 curve (AUC). 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 1 Mar 2017.