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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - Change from baseline in HbA1c after 26 weeks of treatment.
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [1] 0 0
Change From Baseline in Body Weight - Change from baseline in body weight after 26 weeks of treatment.
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [2] 0 0
Number of Treatment-emergent Confirmed Hypoglycaemic Episodes - Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL).
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This trial is conducted globally. The aim of the trial is to compare 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.

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).
Trial website
https://clinicaltrials.gov/show/NCT02100475
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

Summary results
Other publications