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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin. Dose individually adjusted.
Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.
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Fresno, California, United States
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Fort Lauderdale, Florida, United States
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Gurnee, Illinois, United States
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Lexington, Kentucky, United States
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Slidell, Louisiana, United States
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c after 26 weeks of treatment.
Time frame: Week 0, week 26
Change From Baseline in Body Weight
Change from baseline in body weight after 26 weeks of treatment.
Time frame: Week 0, week 26
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).
Time frame: Week 0 - 26
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Altoona, Pennsylvania, United States
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Renton, Washington, United States
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Corrientes, Argentina
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