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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02100475




Registration number
NCT02100475
Ethics application status
Date submitted
27/03/2014
Date registered
1/04/2014
Date last updated
20/01/2017

Titles & IDs
Public title
A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification
Scientific title
A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification (DUAL™ - Intensification)
Secondary ID [1] 0 0
2013-002878-47
Secondary ID [2] 0 0
NN9068-4119
Universal Trial Number (UTN)
Trial acronym
DUAL™
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 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/liraglutide
Treatment: Drugs - insulin aspart

Experimental: Insulin degludec/liraglutide + Metformin -

Active comparator: Insulin degludec/liraglutide + Insulin Aspart + Metformin -


Treatment: Drugs: insulin degludec/liraglutide
Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.

Dose individually adjusted.

Treatment: Drugs: insulin aspart
Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [1] 0 0
Change From Baseline in Body Weight
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [2] 0 0
Number of Treatment-emergent Confirmed Hypoglycaemic Episodes
Timepoint [2] 0 0
Week 0 - 26

Eligibility
Key inclusion criteria
* Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin
* HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinically significant diseases of the major organ systems
* Screening calcitonin above or equal to 50 ng/L

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 3
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
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Wollongong
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Herston
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Ipswich
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Robina
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - East Ringwood
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4305 - Ipswich
Recruitment postcode(s) [4] 0 0
4226 - Robina
Recruitment postcode(s) [5] 0 0
3135 - East Ringwood
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Capital Federal
Country [10] 0 0
Argentina
State/province [10] 0 0
Corrientes
Country [11] 0 0
Argentina
State/province [11] 0 0
Salta
Country [12] 0 0
Argentina
State/province [12] 0 0
Zarate
Country [13] 0 0
Greece
State/province [13] 0 0
Athens
Country [14] 0 0
Greece
State/province [14] 0 0
Ioannina
Country [15] 0 0
Greece
State/province [15] 0 0
Larissa
Country [16] 0 0
Greece
State/province [16] 0 0
Thessaloniki
Country [17] 0 0
Hungary
State/province [17] 0 0
Eger
Country [18] 0 0
Hungary
State/province [18] 0 0
Gyor
Country [19] 0 0
Hungary
State/province [19] 0 0
Gyula
Country [20] 0 0
Hungary
State/province [20] 0 0
Miskolc
Country [21] 0 0
Mexico
State/province [21] 0 0
Hidalgo
Country [22] 0 0
Mexico
State/province [22] 0 0
Morelos
Country [23] 0 0
Mexico
State/province [23] 0 0
México, D.F.
Country [24] 0 0
Mexico
State/province [24] 0 0
Monterrey
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Kazan
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Kirov
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Novosibirsk
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Saint-Petersburg
Country [30] 0 0
Russian Federation
State/province [30] 0 0
St. Petersburg
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Tomsk
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Volgograd
Country [33] 0 0
Slovakia
State/province [33] 0 0
Bardejov
Country [34] 0 0
Slovakia
State/province [34] 0 0
Dolny Kubin
Country [35] 0 0
Slovakia
State/province [35] 0 0
Kosice
Country [36] 0 0
Slovakia
State/province [36] 0 0
Levice
Country [37] 0 0
Slovakia
State/province [37] 0 0
Poprad
Country [38] 0 0
Slovakia
State/province [38] 0 0
Povazska Bystrica
Country [39] 0 0
Slovakia
State/province [39] 0 0
Prievidza
Country [40] 0 0
Slovakia
State/province [40] 0 0
Trnava
Country [41] 0 0
Slovakia
State/province [41] 0 0
Velky Meder
Country [42] 0 0
South Africa
State/province [42] 0 0
Gauteng
Country [43] 0 0
South Africa
State/province [43] 0 0
KwaZulu-Natal
Country [44] 0 0
South Africa
State/province [44] 0 0
North West
Country [45] 0 0
South Africa
State/province [45] 0 0
Alberton
Country [46] 0 0
Spain
State/province [46] 0 0
Almería
Country [47] 0 0
Spain
State/province [47] 0 0
Granada
Country [48] 0 0
Spain
State/province [48] 0 0
Palma de Mallorca
Country [49] 0 0
Spain
State/province [49] 0 0
Sevilla
Country [50] 0 0
Spain
State/province [50] 0 0
Valencia

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02100475