DiabetesPhase 2NCT00842361

Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

A Phase 2 study testing insulin degludec/insulin aspart and biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 8 sites in Japan.

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

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin degludec/insulin aspart and biphasic insulin aspart 30
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 8 sitesJapan
Study dates: Jan 2009to Jun 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with type 2 diabetes mellitus
Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
HbA1c below 10.0%
Body Mass Index (BMI) < 30.0 kg/m^2

Who cannot join

Known hypoglycaemia unawareness or recurrent major hypoglycaemia
Current treatment with total insulin dose of more than 100 U or IU/day
Current treatment or expected to start treatment with systemic corticosteroid
Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer [thiazolidinedione: TZD]) within the last 12 weeks prior to screening

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Japan8 sites

Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103 0002
Novo Nordisk Investigational Site
Miyazaki, 880 0034
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, 311 0113
Novo Nordisk Investigational Site
Ota-ku, Tokyo, 144 0035
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, 323 0022
Novo Nordisk Investigational Site
Sendai, 980 0021
Novo Nordisk Investigational Site
Shizuoka, 424 0853
Novo Nordisk Investigational Site
Tagajō-shi, 985 0852

Other trials in Japan

About this study

Official title: A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/insulin aspart, biphasic insulin aspart 30
Medical subject headings: Diabetes Mellitus, 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 aspartDrug
The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.
biphasic insulin aspart 30Drug
The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.

Study groups in NCT00842361
Study group	Role	What they receive
Mix30	Active comparator	Not described Receives: Drug: biphasic insulin aspart 30
SIAC	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart

What is being measured

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

Rate of Major and Minor Hypoglycaemic Episodes
Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.
Measured: Week 0 to Week 6 + 5 days follow up
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).
Measured: Week 0 to Week 6 + 5 days follow up

Secondary outcomes (5)

Number of Treatment Emergent Adverse Events (AEs)
Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Measured: Week 0 to Week 6 + 5 days follow up
Change in Body Weight
Change from baseline in body weight after 6 weeks of treatment
Measured: Week 0, Week 6
Electrocardiogram (ECG) Worsening
The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.
Measured: Week 0, Week 6
Diastolic BP (Blood Pressure)
Values at baseline (Week 0) and at Week 6
Measured: Week 0, Week 6
Systolic BP (Blood Pressure)
Values at baseline (Week 0) and at Week 6
Measured: Week 0, Week 6.

Timeline

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

Jan 2009Jun 2009

First posted12 Feb 2009 (estimated)
Study startJan 2009
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00842361
Sponsor's protocol ID: NN5401-3570
Other IDs: JapicCTI-090712
Status last verified: Dec 2016
First submitted: 11 Feb 2009
Last updated: 9 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Onishi Y, Yamada K, Zacho J, Ekelund J, Iwamoto Y. Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial. J Diabetes Investig. 2017 Mar;8(2):210-217. doi: 10.1111/jdi.12569. Epub 2016 Oct 7.
PubMed 27560769

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 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00842361
Acronym / sponsor ID: NN5401-3570
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 12 Feb 2009 (estimated)
Results: Posted 20 Nov 2015

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: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mix30	Active comparator	Drug: biphasic insulin aspart 30
SIAC	Experimental	Drug: insulin degludec/insulin aspart

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects with type 2 diabetes mellitus
Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
HbA1c below 10.0%
Body Mass Index (BMI) < 30.0 kg/m^2

Key exclusion criteria (4 listed)

Known hypoglycaemia unawareness or recurrent major hypoglycaemia
Current treatment with total insulin dose of more than 100 U or IU/day
Current treatment or expected to start treatment with systemic corticosteroid
Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer [thiazolidinedione: TZD]) within the last 12 weeks prior to screening

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 aspartThe insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.	Drug	SIAC
biphasic insulin aspart 30The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.	Drug	Mix30

Primary outcome

Rate of Major and Minor Hypoglycaemic Episodes
Time frame: Week 0 to Week 6 + 5 days follow up
Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Time frame: Week 0 to Week 6 + 5 days follow up
Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).

5 secondary outcomes

Number of Treatment Emergent Adverse Events (AEs)
Time frame: Week 0 to Week 6 + 5 days follow up
Change in Body Weight
Time frame: Week 0, Week 6
Electrocardiogram (ECG) Worsening
Time frame: Week 0, Week 6
Diastolic BP (Blood Pressure)
Time frame: Week 0, Week 6
Systolic BP (Blood Pressure)
Time frame: Week 0, Week 6.

Results and safety

Results posted to the registry on 20 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SIAC	33	32
Mix30	33	31

Primary outcome: Rate of Major and Minor Hypoglycaemic Episodes

Time frame: Week 0 to Week 6 + 5 days follow up. Number. Unit: Episodes /year of patient exposure

Measure	SIAC n = 33	Mix30 n = 32
Major	0	0
Minor	13.63	21.83

Population analysed: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Primary outcome: Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

Time frame: Week 0 to Week 6 + 5 days follow up. Number. Unit: Episodes /year of patient exposure

Measure	SIAC n = 33	Mix30 n = 32
Major	0	0
Minor	0.99	2.03

Population analysed: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a time frame of 6 weeks + 5 days follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SIAC	1 of 33 (3%)	5 of 33 (15.2%)	Not reported
Mix30	0 of 32 (0%)	3 of 32 (9.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27560769Onishi Y, Yamada K, Zacho J, Ekelund J, Iwamoto Y. Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial. J Diabetes Investig. 2017 Mar;8(2):210-217. doi: 10.1111/jdi.12569. Epub 2016 Oct 7.
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 Pharma Ltd.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing insulin degludec/insulin aspart and biphasic insulin aspart 30 in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 8 sites in Japan.

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 4 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 9 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 8 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Major and Minor Hypoglycaemic Episodes (time frame: Week 0 to Week 6 + 5 days follow up). 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?

On the ClinicalTrials.gov record for NCT00842361, 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 9 Feb 2017.