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DiabetesPhase 2NCT00613951

Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes

A Phase 2 study testing insulin degludec/insulin aspart, biphasic insulin aspart and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 31 sites in 5 countries.

Completed

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

Official record
Search all trials

Trial summary

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
insulin degludec/insulin aspart, biphasic insulin aspart and metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
31 sitesin 5 countries
Study dates
Jan 2008to Aug 2008
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
  • Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
  • Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC)
  • HbA1c, 7.0-11.0 % (both inclusive)
  • Body Mass Index (BMI), 25.0-37.0 kg/m^2 (both inclusive)

Who cannot join

  • Metformin contraindication according to local practice
  • Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1
  • Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
  • Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product

Trial locations and contacts

31 sites in 5 countries.

31 sites in 5 countries

Poland8 sites

  • Novo Nordisk Investigational Site

    Bydgoszcz, 85-822

  • Novo Nordisk Investigational Site

    Gniewkowo, 88-140

  • Novo Nordisk Investigational Site

    Nysa, 48-300

  • Novo Nordisk Investigational Site

    Płock, 09-400

  • Novo Nordisk Investigational Site

    Szczecin, 70-483

  • Novo Nordisk Investigational Site

    Tychy, 43-100

  • Novo Nordisk Investigational Site

    Warsaw, 02-507

  • Novo Nordisk Investigational Site

    Wroclaw, 50-127

Other trials in Poland

France7 sites

  • Novo Nordisk Investigational Site

    Bar-le-Duc, 55000

  • Novo Nordisk Investigational Site

    Grenoble, 38043

  • Novo Nordisk Investigational Site

    Hayange, 57700

  • Novo Nordisk Investigational Site

    La Rochelle, 17019

  • Novo Nordisk Investigational Site

    Nanterre, 92014

  • Novo Nordisk Investigational Site

    Nevers, 58033

  • Novo Nordisk Investigational Site

    Pointe à Pitre, 97159

Other trials in France

Germany7 sites

  • Novo Nordisk Investigational Site

    Berlin, 12163

  • Novo Nordisk Investigational Site

    Pirna, 01796

  • Novo Nordisk Investigational Site

    Riesa, 01587

  • Novo Nordisk Investigational Site

    Saarbrücken, 66121

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386

  • Novo Nordisk Investigational Site

    Völklingen, 66333

  • Novo Nordisk Investigational Site

    Wangen, 88239

Other trials in Germany

Spain5 sites

  • Novo Nordisk Investigational Site

    Almería, 04001

  • Novo Nordisk Investigational Site

    Barcelona, 08035

  • Novo Nordisk Investigational Site

    Granada, 18012

  • Novo Nordisk Investigational Site

    Madrid, 28034

  • Novo Nordisk Investigational Site

    San Juan, 03550

Other trials in Spain

Finland4 sites

  • Novo Nordisk Investigational Site

    Helsinki, 00260

  • Novo Nordisk Investigational Site

    Kuopio, 70210

  • Novo Nordisk Investigational Site

    Lahti, 15110

  • Novo Nordisk Investigational Site

    Pori, FI-28100

Other trials in Finland

About this study

Official title: A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Being tested
insulin degludec/insulin aspart, biphasic insulin aspart, metformin
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

    Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

  • insulin degludec/insulin aspartDrug

    Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

  • biphasic insulin aspartDrug

    Treat-to-target dose titration scheme, injection s.c., twice daily

  • metforminDrug

    Tablets, 1500-2000 mg/daily

Study groups in NCT00613951
Study groupRoleWhat they receive
SIAC 30 (B)ExperimentalNot described
Receives: Drug: insulin degludec/insulin aspart; Drug: metformin
SIAC 45 (B)ExperimentalNot described
Receives: Drug: insulin degludec/insulin aspart; Drug: metformin
BIAsp 30Active comparatorNot described
Receives: Drug: biphasic insulin aspart; Drug: metformin

What is being measured

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

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Change from baseline in HbA1c after 16 weeks of treatment

    Measured: Week 0, Week 16

Secondary outcomes (11)

  1. Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

    Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.

    Measured: Week 16

  2. Rate of Major and Minor Hypoglycaemic Episodes

    Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.

    Measured: Week 0 to Week 16 + 5 days follow up

  3. Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

    Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).

    Measured: Week 0 to Week 16 + 5 days follow up

  4. Rate of Treatment Emergent Adverse Events (AEs)

    Corresponds to rate of AEs per 100 patient years of exposure. 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 16 + 5 days follow up

  5. Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

    Laboratory values at screening (Week -4) and at Week 16

    Measured: Week -4, Week 16

  6. Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

    Laboratory values at screening (Week -4) and at Week 16

    Measured: Week -4, Week 16

  7. Laboratory Safety Parameters (Biochemistry): Serum Creatinine

    Laboratory values at screening (Week -4) and at Week 16

    Measured: Week -4, Week 16

  8. Vital Signs: Diastolic Blood Pressure (BP)

    Values at baseline (Week 0) and at Week 16

    Measured: Week 0, Week 16

  9. Vital Signs: Systolic Blood Pressure (BP)

    Values at baseline (Week 0) and at Week 16

    Measured: Week 0, Week 16

  10. Vital Signs: Pulse

    Values at baseline (Week 0) and at Week 16

    Measured: Week 0, Week 16

  11. Physical Examination

    Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.

    Measured: Week -4, Week 8, Week 16

Timeline

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

  1. First posted13 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

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
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00613951
Sponsor's protocol ID
NN5401-1792
Other IDs
2007-002462-35
Status last verified
Feb 2017
First submitted
30 Jan 2008
Last updated
20 Mar 2017
Data monitoring committee
No

Publications

  • Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Munoz-Torres M, Donnet JP, Endahl L, Skjoth TV, Vaag A. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol. 2012 Aug;167(2):287-94. doi: 10.1530/EJE-12-0293. Epub 2012 Jun 1.

    PubMed 22660026

  • Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4.

    PubMed 22946603

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing insulin degludec/insulin aspart, biphasic insulin aspart and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 31 sites in 5 countries.

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 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 20 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 31 sites in Poland, France, Germany, Spain, Finland. 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 1 Dec 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?

Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 16). 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 NCT00613951, which also lists 2 linked publications.

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 20 Mar 2017.

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