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™)
Status and phase
Completed
Phase 3
Conditions
Diabetes
Diabetes Mellitus, Type 2
Treatments
Drug: insulin aspart
Drug: insulin degludec/liraglutide
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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).
Enrollment
31 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Exclusion criteria
- Clinically significant diseases of the major organ systems
- Screening calcitonin above or equal to 50 ng/L
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
31 participants in 2 patient groups
Insulin degludec/liraglutide + Metformin
Experimental group
Treatment:
Drug: insulin degludec/liraglutide
Insulin degludec/liraglutide + Insulin Aspart + Metformin
Active Comparator group
Treatment:
Drug: insulin degludec/liraglutide
Drug: insulin aspart
Trial contacts and locations
60
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Data sourced from clinicaltrials.gov
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