- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00612040
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
January 18, 2017 updated by: Novo Nordisk A/S
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Geelong, Australia, 3220
- Novo Nordisk Investigational Site
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Miranda, Australia, 2228
- Novo Nordisk Investigational Site
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New South Wales
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Wollongong, New South Wales, Australia, 2500
- Novo Nordisk Investigational Site
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South Australia
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Keswick, South Australia, Australia, 5035
- Novo Nordisk Investigational Site
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Victoria
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East Ringwood, Victoria, Australia, 3135
- Novo Nordisk Investigational Site
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Aschaffenburg, Germany, 63739
- Novo Nordisk Investigational Site
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Bad Kreuznach, Germany, 55545
- Novo Nordisk Investigational Site
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Dresden, Germany, 01219
- Novo Nordisk Investigational Site
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Hamburg, Germany, 22607
- Novo Nordisk Investigational Site
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Hohenmölsen, Germany, 06679
- Novo Nordisk Investigational Site
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Neuwied, Germany, 56564
- Novo Nordisk Investigational Site
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St. Ingbert, Germany, 66386
- Novo Nordisk Investigational Site
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Bergen, Norway, 5021
- Novo Nordisk Investigational Site
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Bergen, Norway, NO-5012
- Novo Nordisk Investigational Site
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Elverum, Norway, 2408
- Novo Nordisk Investigational Site
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Kristiansand S, Norway, 4604
- Novo Nordisk Investigational Site
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Oslo, Norway, 0586
- Novo Nordisk Investigational Site
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Stavanger, Norway, 4011
- Novo Nordisk Investigational Site
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Alingsås, Sweden, 441 83
- Novo Nordisk Investigational Site
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Karlstad, Sweden, 651 85
- Novo Nordisk Investigational Site
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Lund, Sweden, 221 85
- Novo Nordisk Investigational Site
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Stockholm, Sweden, 112 81
- Novo Nordisk Investigational Site
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Stockholm, Sweden, 182 88
- Novo Nordisk Investigational Site
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Umeå, Sweden, 901 85
- Novo Nordisk Investigational Site
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California
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Walnut Creek, California, United States, 94598
- Novo Nordisk Investigational Site
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Hawaii
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Honolulu, Hawaii, United States, 96814
- Novo Nordisk Investigational Site
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Idaho
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Idaho Falls, Idaho, United States, 83404-7596
- Novo Nordisk Investigational Site
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Iowa
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Des Moines, Iowa, United States, 50314
- Novo Nordisk Investigational Site
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Maryland
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Hyattsville, Maryland, United States, 20782
- Novo Nordisk Investigational Site
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Novo Nordisk Investigational Site
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Texas
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Dallas, Texas, United States, 75230
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75231
- Novo Nordisk Investigational Site
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Washington
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Renton, Washington, United States, 98057
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 1 diabetes for at least one year
- HbA1c 7-11% (both inclusive)
- Treated with insulin for at least six months - any regimen
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: IGlar
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Treat-to-target dose titration scheme, injection s.c., once daily
Treat-to-target dose titration scheme, injection s.c.
(under the skin), 3 times daily
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Experimental: SIBA (D)
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Formulation 1: Treat-to-target dose titration scheme, injection s.c.
(under the skin), once daily
Formulation 2: Treat-to-target dose titration scheme, injection s.c.
(under the skin), once daily
Treat-to-target dose titration scheme, injection s.c.
(under the skin), 3 times daily
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Experimental: SIBA (E)
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Formulation 1: Treat-to-target dose titration scheme, injection s.c.
(under the skin), once daily
Formulation 2: Treat-to-target dose titration scheme, injection s.c.
(under the skin), once daily
Treat-to-target dose titration scheme, injection s.c.
(under the skin), 3 times daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 16
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Change from baseline in HbA1c after 16 weeks of treatment
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Week 0, Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Major and Minor Hypoglycaemic Episodes
Time Frame: Week 0 to Week 16 + 5 days follow up
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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.
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Week 0 to Week 16 + 5 days follow up
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Rate of Treatment Emergent Adverse Events (AEs)
Time Frame: Week 0 to Week 16 + 5 days follow up
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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.
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Week 0 to Week 16 + 5 days follow up
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Vital Signs: Pulse
Time Frame: Week 0, Week 16
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Values at baseline (Week 0) and at Week 16
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Week 0, Week 16
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Change in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, Week 16
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Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment
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Week 0, Week 16
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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Time Frame: Week 16
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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.
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Week 16
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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Time Frame: Week 0 to Week 16 + 5 days follow up
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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).
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Week 0 to Week 16 + 5 days follow up
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Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Time Frame: Week -1, Week 16
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Laboratory values at screening (Week -1) and at Week 16
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Week -1, Week 16
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Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Time Frame: Week -1, Week 16
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Laboratory values at screening (Week -1) and at Week 16
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Week -1, Week 16
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Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Time Frame: Week -1, Week 16
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Laboratory values at screening (Week -1) and at Week 16
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Week -1, Week 16
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Vital Signs: Diastolic BP (Blood Pressure)
Time Frame: Week 0, Week 16
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Values at baseline (Week 0) and at Week 16
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Week 0, Week 16
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Vital Signs: Systolic BP (Blood Pressure)
Time Frame: Week 0, Week 16
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Values at baseline (Week 0) and at Week 16
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Week 0, Week 16
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Physical Examination
Time Frame: Week -1, Week 8, Week 16
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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.
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Week -1, Week 8, Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
January 25, 2008
First Submitted That Met QC Criteria
January 29, 2008
First Posted (Estimate)
February 11, 2008
Study Record Updates
Last Update Posted (Actual)
March 3, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1250-1835
- 2007-002474-60 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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