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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2007-002474-60
Secondary ID [2] 0 0
NN1250-1835
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Glycosylated Haemoglobin (HbA1c)
Timepoint [1] 0 0
Week 0, Week 16
Secondary outcome [1] 0 0
Change in Fasting Plasma Glucose (FPG)
Timepoint [1] 0 0
Week 0, Week 16
Secondary outcome [2] 0 0
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Rate of Major and Minor Hypoglycaemic Episodes
Timepoint [3] 0 0
Week 0 to Week 16 + 5 days follow up
Secondary outcome [4] 0 0
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Timepoint [4] 0 0
Week 0 to Week 16 + 5 days follow up
Secondary outcome [5] 0 0
Rate of Treatment Emergent Adverse Events (AEs)
Timepoint [5] 0 0
Week 0 to Week 16 + 5 days follow up
Secondary outcome [6] 0 0
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Timepoint [6] 0 0
Week -1, Week 16
Secondary outcome [7] 0 0
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Timepoint [7] 0 0
Week -1, Week 16
Secondary outcome [8] 0 0
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Timepoint [8] 0 0
Week -1, Week 16
Secondary outcome [9] 0 0
Vital Signs: Diastolic BP (Blood Pressure)
Timepoint [9] 0 0
Week 0, Week 16
Secondary outcome [10] 0 0
Vital Signs: Systolic BP (Blood Pressure)
Timepoint [10] 0 0
Week 0, Week 16
Secondary outcome [11] 0 0
Vital Signs: Pulse
Timepoint [11] 0 0
Week 0, Week 16
Secondary outcome [12] 0 0
Physical Examination
Timepoint [12] 0 0
Week -1, Week 8, Week 16

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Wollongong
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - East Ringwood
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Geelong
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Miranda
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
5035 - Keswick
Recruitment postcode(s) [3] 0 0
3135 - East Ringwood
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
2228 - Miranda
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Germany
State/province [9] 0 0
Aschaffenburg
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Kreuznach
Country [11] 0 0
Germany
State/province [11] 0 0
Dresden
Country [12] 0 0
Germany
State/province [12] 0 0
Hamburg
Country [13] 0 0
Germany
State/province [13] 0 0
Hohenmölsen
Country [14] 0 0
Germany
State/province [14] 0 0
Neuwied
Country [15] 0 0
Germany
State/province [15] 0 0
St. Ingbert
Country [16] 0 0
Norway
State/province [16] 0 0
Bergen
Country [17] 0 0
Norway
State/province [17] 0 0
Elverum
Country [18] 0 0
Norway
State/province [18] 0 0
Kristiansand S
Country [19] 0 0
Norway
State/province [19] 0 0
Oslo
Country [20] 0 0
Norway
State/province [20] 0 0
Stavanger
Country [21] 0 0
Sweden
State/province [21] 0 0
Alingsås
Country [22] 0 0
Sweden
State/province [22] 0 0
Karlstad
Country [23] 0 0
Sweden
State/province [23] 0 0
Lund
Country [24] 0 0
Sweden
State/province [24] 0 0
Stockholm
Country [25] 0 0
Sweden
State/province [25] 0 0
Umeå

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT00612040