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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00612040
Registration number
NCT00612040
Ethics application status
Date submitted
25/01/2008
Date registered
11/02/2008
Date last updated
3/03/2017
Titles & IDs
Public title
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
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Scientific 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
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Secondary ID [1]
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2007-002474-60
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Secondary ID [2]
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NN1250-1835
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
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Diabetes Mellitus, Type 1
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - insulin degludec
Treatment: Drugs - insulin degludec
Treatment: Drugs - insulin glargine
Treatment: Drugs - insulin aspart
Experimental: SIBA (D) -
Experimental: SIBA (E) -
Experimental: IGlar -
Treatment: Drugs: insulin degludec
Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
Treatment: Drugs: insulin degludec
Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
Treatment: Drugs: insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
Treatment: Drugs: insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Glycosylated Haemoglobin (HbA1c)
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Assessment method [1]
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Change from baseline in HbA1c after 16 weeks of treatment
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Timepoint [1]
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Week 0, Week 16
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Secondary outcome [1]
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Change in Fasting Plasma Glucose (FPG)
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Assessment method [1]
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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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Timepoint [1]
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Week 0, Week 16
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Secondary outcome [2]
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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
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Assessment method [2]
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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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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Rate of Major and Minor Hypoglycaemic Episodes
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Assessment method [3]
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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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Timepoint [3]
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Week 0 to Week 16 + 5 days follow up
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Secondary outcome [4]
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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
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Assessment method [4]
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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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Timepoint [4]
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Week 0 to Week 16 + 5 days follow up
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Secondary outcome [5]
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Rate of Treatment Emergent Adverse Events (AEs)
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Assessment method [5]
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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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Timepoint [5]
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Week 0 to Week 16 + 5 days follow up
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Secondary outcome [6]
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Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
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Assessment method [6]
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Laboratory values at screening (Week -1) and at Week 16
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Timepoint [6]
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Week -1, Week 16
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Secondary outcome [7]
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Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
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Assessment method [7]
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Laboratory values at screening (Week -1) and at Week 16
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Timepoint [7]
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Week -1, Week 16
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Secondary outcome [8]
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Laboratory Safety Parameters (Biochemistry): Serum Creatinine
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Assessment method [8]
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Laboratory values at screening (Week -1) and at Week 16
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Timepoint [8]
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Week -1, Week 16
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Secondary outcome [9]
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Vital Signs: Diastolic BP (Blood Pressure)
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Assessment method [9]
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Values at baseline (Week 0) and at Week 16
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Timepoint [9]
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Week 0, Week 16
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Secondary outcome [10]
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Vital Signs: Systolic BP (Blood Pressure)
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Assessment method [10]
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Values at baseline (Week 0) and at Week 16
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Timepoint [10]
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Week 0, Week 16
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Secondary outcome [11]
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Vital Signs: Pulse
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Assessment method [11]
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Values at baseline (Week 0) and at Week 16
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Timepoint [11]
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Week 0, Week 16
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Secondary outcome [12]
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Physical Examination
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Assessment method [12]
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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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Timepoint [12]
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Week -1, Week 8, Week 16
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2008
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Sample size
Target
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Accrual to date
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Final
178
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Wollongong
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Keswick
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - East Ringwood
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Recruitment hospital [4]
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Novo Nordisk Investigational Site - Geelong
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Recruitment hospital [5]
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Novo Nordisk Investigational Site - Miranda
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Recruitment postcode(s) [1]
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2500 - Wollongong
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Recruitment postcode(s) [2]
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5035 - Keswick
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Recruitment postcode(s) [3]
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3135 - East Ringwood
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Recruitment postcode(s) [4]
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3220 - Geelong
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Recruitment postcode(s) [5]
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2228 - Miranda
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Hawaii
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Country [3]
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United States of America
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State/province [3]
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Idaho
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Country [4]
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United States of America
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State/province [4]
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Iowa
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Country [5]
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United States of America
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State/province [5]
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Maryland
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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United States of America
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State/province [8]
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Washington
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Country [9]
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Germany
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State/province [9]
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Aschaffenburg
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Country [10]
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Germany
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State/province [10]
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Bad Kreuznach
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Country [11]
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Germany
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State/province [11]
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Dresden
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Country [12]
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Germany
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State/province [12]
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Hamburg
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Country [13]
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Germany
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State/province [13]
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Hohenmölsen
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Country [14]
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Germany
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State/province [14]
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Neuwied
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Country [15]
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Germany
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State/province [15]
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St. Ingbert
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Country [16]
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Norway
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State/province [16]
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Bergen
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Country [17]
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Norway
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State/province [17]
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Elverum
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Country [18]
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Norway
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State/province [18]
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Kristiansand S
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Country [19]
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Norway
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State/province [19]
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Oslo
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Country [20]
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Norway
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State/province [20]
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Stavanger
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Country [21]
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Sweden
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State/province [21]
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Alingsås
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Country [22]
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Sweden
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State/province [22]
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Karlstad
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Country [23]
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Sweden
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State/province [23]
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Lund
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Country [24]
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Sweden
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State/province [24]
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Stockholm
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Country [25]
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Sweden
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State/province [25]
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Umeå
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00612040
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Registry (GCR, 1452)
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Address
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Novo Nordisk A/S
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00612040
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