DiabetesPhase 1NCT01868568

Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes

A Phase 1 study testing insulin degludec, insulin degludec/insulin aspart 30 and insulin degludec/insulin aspart 40 in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1
What is being tested?: insulin degludec, insulin degludec/insulin aspart 30 and insulin degludec/insulin aspart 40
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 1 siteGermany
Study dates: Apr 2008to Aug 2008
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
Body Mass Index (BMI) between 18.0 and 27.0 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 trialproduct, as judged by the Investigator
A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
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.

Germany1 site

Study site
Neuss, 41460

Other trials in Germany

About this study

Official title: A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.

Conditions: Diabetes, Diabetes Mellitus, Type 1
Being tested: insulin degludec, insulin degludec/insulin aspart 30, insulin degludec/insulin aspart 40, insulin degludec/insulin aspart 45, insulin degludec/insulin aspart 55
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.

insulin degludecDrug
Administered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 30Drug
A single dose administered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 40Drug
A single dose administered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 45Drug
A single dose administered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 55Drug
A single dose administered subcutaneously (s.c., under the skin).
insulin aspartDrug
A single dose administered subcutaneously (s.c., under the skin).
biphasic insulin aspart 30Drug
A single dose administered subcutaneously (s.c., under the skin).
placeboDrug
A single dose administered subcutaneously (s.c., under the skin).

Study groups in NCT01868568
Study group	Role	What they receive
IDegAsp 30 + placebo	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart 30; Drug: placebo
Insulin aspart + insulin degludec - low concentration 1	Experimental	Not described Receives: Drug: insulin degludec; Drug: insulin aspart
IDegAsp 40 + placebo	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart 40; Drug: placebo
Insulin aspart + insulin degludec - high concentration 1	Experimental	Not described Receives: Drug: insulin degludec; Drug: insulin aspart
IDegAsp 45 + placebo	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart 45; Drug: placebo
Insulin aspart + insulin degludec	Experimental	Not described Receives: Drug: insulin degludec; Drug: insulin aspart
IDegAsp 55 + placebo	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart 55; Drug: placebo
Insulin aspart + insulin degludec - high concentration	Experimental	Not described Receives: Drug: insulin degludec; Drug: insulin aspart
BIAsp 30 + placebo	Active comparator	Not described Receives: Drug: biphasic insulin aspart 30; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the insulin aspart concentration curve
Measured: 0-2 hours after dosing

Secondary outcomes (2)

Area under the glucose infusion rate curve
Measured: 0-26 hours after dosing
Area under the serum insulin 454 concentration curve
Measured: 0-120 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Aug 2008

First posted4 Jun 2013 (estimated)
Study startApr 2008
Primary completionAug 2008
Study completionAug 2008

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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01868568
Sponsor's protocol ID: NN5401-1959
Other IDs: 2007-006110-42
Status last verified: Oct 2015
First submitted: 30 May 2013
Last updated: 22 Oct 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes
ClinicalTrials.gov ID: NCT01868568
Acronym / sponsor ID: NN5401-1959
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 4 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
IDegAsp 30 + placebo	Experimental	Drug: insulin degludec/insulin aspart 30, Drug: placebo
Insulin aspart + insulin degludec - low concentration 1	Experimental	Drug: insulin degludec, Drug: insulin aspart
IDegAsp 40 + placebo	Experimental	Drug: insulin degludec/insulin aspart 40, Drug: placebo
Insulin aspart + insulin degludec - high concentration 1	Experimental	Drug: insulin degludec, Drug: insulin aspart
IDegAsp 45 + placebo	Experimental	Drug: insulin degludec/insulin aspart 45, Drug: placebo
Insulin aspart + insulin degludec	Experimental	Drug: insulin degludec, Drug: insulin aspart
IDegAsp 55 + placebo	Experimental	Drug: insulin degludec/insulin aspart 55, Drug: placebo
Insulin aspart + insulin degludec - high concentration	Experimental	Drug: insulin degludec, Drug: insulin aspart
BIAsp 30 + placebo	Active comparator	Drug: biphasic insulin aspart 30, Drug: placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)

Key exclusion criteria (3 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 trialproduct, as judged by the Investigator
A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
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 degludecAdministered subcutaneously (s.c., under the skin).	Drug	Insulin aspart + insulin degludec, Insulin aspart + insulin degludec - high concentration, Insulin aspart + insulin degludec - high concentration 1, Insulin aspart + insulin degludec - low concentration 1
insulin degludec/insulin aspart 30A single dose administered subcutaneously (s.c., under the skin).	Drug	IDegAsp 30 + placebo
insulin degludec/insulin aspart 40A single dose administered subcutaneously (s.c., under the skin).	Drug	IDegAsp 40 + placebo
insulin degludec/insulin aspart 45A single dose administered subcutaneously (s.c., under the skin).	Drug	IDegAsp 45 + placebo
insulin degludec/insulin aspart 55A single dose administered subcutaneously (s.c., under the skin).	Drug	IDegAsp 55 + placebo
insulin aspartA single dose administered subcutaneously (s.c., under the skin).	Drug	Insulin aspart + insulin degludec, Insulin aspart + insulin degludec - high concentration, Insulin aspart + insulin degludec - high concentration 1, Insulin aspart + insulin degludec - low concentration 1
biphasic insulin aspart 30A single dose administered subcutaneously (s.c., under the skin).	Drug	BIAsp 30 + placebo
placeboA single dose administered subcutaneously (s.c., under the skin).	Drug	BIAsp 30 + placebo, IDegAsp 30 + placebo, IDegAsp 40 + placebo, IDegAsp 45 + placebo, IDegAsp 55 + placebo

Primary outcome

Area under the insulin aspart concentration curve
Time frame: 0-2 hours after dosing

2 secondary outcomes

Area under the glucose infusion rate curve
Time frame: 0-26 hours after dosing
Area under the serum insulin 454 concentration curve
Time frame: 0-120 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 22 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?

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 3 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 22 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 (time frame: 0-2 hours after 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 NCT01868568.

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 22 Oct 2015.