DiabetesPhase 1NCT01865305
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes
A Phase 1 study testing insulin degludec/insulin aspart 30, insulin degludec/insulin aspart 40 and insulin degludec/insulin aspart 50 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 different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec… Read more about this study
- Who is it for?
- Ages 18 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin degludec/insulin aspart 30, insulin degludec/insulin aspart 40 and insulin degludec/insulin aspart 50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Feb 2007
- 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 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
- ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
- ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
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- Diagnosed with type 2 diabetes mellitus for at least 12 months
- Treated with insulin for the last 3 months prior to screening.
- Body Mass Index (BMI) between 22.0 and 35.0 kg/m^2 (both inclusive)
Who cannot join
- A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
- A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Multiple Period Crossover Trial Comparing Insulin 454 and Insulin Aspart Premixes With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared With Biphasic Insulin Aspart 30 (NovoMix® 30) in Male Subjects With Type 1 and Type 2 Diabetes Mellitus
This trial is conducted in Europe. The aim of this trial is to compare different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.
Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments.
Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.
- Being tested
- insulin degludec/insulin aspart 30, insulin degludec/insulin aspart 40, insulin degludec/insulin aspart 50, insulin degludec, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludec/insulin aspart 30Drug
Single dose administrated subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 40Drug
Single dose administrated subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 50Drug
Single dose administrated subcutaneously (s.c., under the skin).
insulin degludecDrug
Single dose administrated subcutaneously (s.c., under the skin).
insulin aspartDrug
Single dose administrated subcutaneously (s.c., under the skin).
biphasic insulin aspart 30Drug
Single dose administrated subcutaneously (s.c., under the skin) as comparator.
insulin degludec/insulin aspart 40Drug
Single dose administrated subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 50Drug
Single dose administrated subcutaneously (s.c., under the skin).
biphasic insulin aspart 30Drug
Single dose administrated subcutaneously (s.c., under the skin).
| Study group | Role | What they receive |
|---|---|---|
| Trial part 1 | Experimental | Not described Receives: Drug: insulin degludec/insulin aspart 30; Drug: insulin degludec/insulin aspart 40; Drug: insulin degludec/insulin aspart 50; Drug: insulin degludec; Drug: insulin aspart; Drug: biphasic insulin aspart 30 |
| Trial part 2 | Experimental | Not described Receives: Drug: insulin degludec/insulin aspart 40; Drug: insulin degludec/insulin aspart 50; Drug: biphasic insulin aspart 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)
Measured: 0-2 hours after dosing
Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)
Measured: 0-24 hours after dosing
Secondary outcomes (2)
Area under the glucose infusion rate curve
Measured: 0-24 hours after dosing
Area under the serum insulin degludec concentration curve
Measured: 0-96 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startSep 2006
- Primary completionFeb 2007
- Study completionFeb 2007
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
- 59 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
- NCT01865305
- Sponsor's protocol ID
- NN5401-1738
- Other IDs
- 2006-002430-37
- Status last verified
- Oct 2015
- First submitted
- 27 May 2013
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Multiple Period Crossover Trial Comparing Insulin 454 and Insulin Aspart Premixes With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared With Biphasic Insulin Aspart 30 (NovoMix® 30) in Male Subjects With Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01865305
- Acronym / sponsor ID
- NN5401-1738
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 30 May 2013 (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 different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.
Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments.
Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial part 1 | Experimental | Drug: insulin degludec/insulin aspart 30, Drug: insulin degludec/insulin aspart 40, Drug: insulin degludec/insulin aspart 50, Drug: insulin degludec, Drug: insulin aspart, Drug: biphasic insulin aspart 30 |
| Trial part 2 | Experimental | Drug: insulin degludec/insulin aspart 40, Drug: insulin degludec/insulin aspart 50, Drug: biphasic insulin aspart 30 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
- ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
Key exclusion criteria (2 listed)
- A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
- A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
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 degludec/insulin aspart 30Single dose administrated subcutaneously (s.c., under the skin). | Drug | Trial part 1 |
| insulin degludec/insulin aspart 40Single dose administrated subcutaneously (s.c., under the skin). | Drug | Trial part 1 |
| insulin degludec/insulin aspart 50Single dose administrated subcutaneously (s.c., under the skin). | Drug | Trial part 1 |
| insulin degludecSingle dose administrated subcutaneously (s.c., under the skin). | Drug | Trial part 1 |
| insulin aspartSingle dose administrated subcutaneously (s.c., under the skin). | Drug | Trial part 1 |
| biphasic insulin aspart 30Single dose administrated subcutaneously (s.c., under the skin) as comparator. | Drug | Trial part 1 |
| insulin degludec/insulin aspart 40Single dose administrated subcutaneously (s.c., under the skin). | Drug | Trial part 2 |
| insulin degludec/insulin aspart 50Single dose administrated subcutaneously (s.c., under the skin). | Drug | Trial part 2 |
| biphasic insulin aspart 30Single dose administrated subcutaneously (s.c., under the skin). | Drug | Trial part 2 |
Primary outcome
Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)
Time frame: 0-2 hours after dosing
Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)
Time frame: 0-24 hours after dosing
2 secondary outcomes
Area under the glucose infusion rate curve
Time frame: 0-24 hours after dosing
Area under the serum insulin degludec concentration curve
Time frame: 0-96 hours after dosing
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 23 Oct 2015.
- 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 degludec/insulin aspart 30, insulin degludec/insulin aspart 40 and insulin degludec/insulin aspart 50 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 9 inclusion and 2 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 23 Oct 2015. 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 insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes) (time frame: 0-2 hours after dosing). 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 23 Oct 2015.