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DiabetesPhase 2NCT00612040

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

A Phase 2 study testing insulin degludec, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 33 sites in 5 countries.

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 Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 1
What is being tested?
insulin degludec, insulin glargine and insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
33 sitesin 5 countries
Study dates
Jan 2008to Jun 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

  • Type 1 diabetes for at least one year
  • HbA1c 7-11% (both inclusive)
  • Treated with insulin for at least six months - any regimen

Who cannot join

  • Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 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 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

33 sites in 5 countries.

33 sites in 5 countries

United States9 sites

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75231

  • Novo Nordisk Investigational Site

    Des Moines, Iowa, 50314

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii, 96814

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland, 20782

  • Novo Nordisk Investigational Site

    Idaho Falls, Idaho, 83404-7596

  • Novo Nordisk Investigational Site

    Renton, Washington, 98057

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

Other trials in United States

Germany7 sites

  • Novo Nordisk Investigational Site

    Aschaffenburg, 63739

  • Novo Nordisk Investigational Site

    Bad Kreuznach, 55545

  • Novo Nordisk Investigational Site

    Dresden, 01219

  • Novo Nordisk Investigational Site

    Hamburg, 22607

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679

  • Novo Nordisk Investigational Site

    Neuwied, 56564

  • Novo Nordisk Investigational Site

    Saint Ingbert, 66386

Other trials in Germany

Norway6 sites

  • Novo Nordisk Investigational Site

    Bergen, 5021

  • Novo Nordisk Investigational Site

    Bergen, NO-5012

  • Novo Nordisk Investigational Site

    Elverum, 2408

  • Novo Nordisk Investigational Site

    Kristiansand, 4604

  • Novo Nordisk Investigational Site

    Oslo, 0586

  • Novo Nordisk Investigational Site

    Stavanger, 4011

Other trials in Norway

Sweden6 sites

  • Novo Nordisk Investigational Site

    Alingsås, 441 83

  • Novo Nordisk Investigational Site

    Karlstad, 651 85

  • Novo Nordisk Investigational Site

    Lund, 221 85

  • Novo Nordisk Investigational Site

    Stockholm, 112 81

  • Novo Nordisk Investigational Site

    Stockholm, 182 88

  • Novo Nordisk Investigational Site

    Umeå, 901 85

Other trials in Sweden

Australia5 sites

  • Novo Nordisk Investigational Site

    East Ringwood, Victoria, 3135

  • Novo Nordisk Investigational Site

    Geelong, 3220

  • Novo Nordisk Investigational Site

    Keswick, South Australia, 5035

  • Novo Nordisk Investigational Site

    Miranda, 2228

  • Novo Nordisk Investigational Site

    Wollongong, New South Wales, 2500

Other trials in Australia

About this study

Official title: A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Type 1 Diabetes

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

Being tested
insulin degludec, insulin glargine, insulin aspart
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

    Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily

  • insulin degludecDrug

    Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily

  • insulin glargineDrug

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

  • insulin aspartDrug

    Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily

Study groups in NCT00612040
Study groupRoleWhat they receive
SIBA (D)ExperimentalNot described
Receives: Drug: insulin degludec; Drug: insulin aspart
SIBA (E)ExperimentalNot described
Receives: Drug: insulin degludec; Drug: insulin aspart
IGlarExperimentalNot described
Receives: Drug: insulin glargine; Drug: insulin aspart

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 (12)

  1. Change in Fasting Plasma Glucose (FPG)

    Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment

    Measured: Week 0, Week 16

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

    Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) 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, bedtime, at 4 am and before breakfast.

    Measured: Week 16

  3. Rate of Major and Minor Hypoglycaemic Episodes

    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

  4. 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 06:00 (excluded).

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

  5. 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

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

    Laboratory values at screening (Week -1) and at Week 16

    Measured: Week -1, Week 16

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

    Laboratory values at screening (Week -1) and at Week 16

    Measured: Week -1, Week 16

  8. Laboratory Safety Parameters (Biochemistry): Serum Creatinine

    Laboratory values at screening (Week -1) and at Week 16

    Measured: Week -1, Week 16

  9. Vital Signs: Diastolic BP (Blood Pressure)

    Values at baseline (Week 0) and at Week 16

    Measured: Week 0, Week 16

  10. Vital Signs: Systolic BP (Blood Pressure)

    Values at baseline (Week 0) and at Week 16

    Measured: Week 0, Week 16

  11. Vital Signs: Pulse

    Values at baseline (Week 0) and at Week 16

    Measured: Week 0, Week 16

  12. Physical Examination

    Physical examination was performed at screening (week -1), 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 -1, 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 posted11 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2008
  4. Study completionJun 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
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00612040
Sponsor's protocol ID
NN1250-1835
Other IDs
2007-002474-60
Status last verified
Jan 2017
First submitted
25 Jan 2008
Last updated
3 Mar 2017
Data monitoring committee
No

Publications

  • Birkeland KI, Home PD, Wendisch U, Ratner RE, Johansen T, Endahl LA, Lyby K, Jendle JH, Roberts AP, DeVries JH, Meneghini LF. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care. 2011 Mar;34(3):661-5. doi: 10.2337/dc10-1925. Epub 2011 Jan 26.

    PubMed 21270174

  • Home PD, Meneghini L, Wendisch U, Ratner RE, Johansen T, Christensen TE, Jendle J, Roberts AP, Birkeland KI. Improved health status with insulin degludec compared with insulin glargine in people with type 1 diabetes. Diabet Med. 2012 Jun;29(6):716-20. doi: 10.1111/j.1464-5491.2011.03547.x.

    PubMed 22150786

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing insulin degludec, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 33 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 3 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 3 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 33 sites in United States, Germany, Norway, Sweden, Australia. 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 16 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?

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 NCT00612040, 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 3 Mar 2017.

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