This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
435
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Injected subcutaneously (under the skin) once daily.
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Garden Grove, California, United States
Novo Nordisk Investigational Site
La Jolla, California, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from baseline to 26 weeks.
Time frame: Week 0, Week 26
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Percentage of subjects having HbA1c below 7% at week 26.
Time frame: Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Percentage of subjects having HbA1c below 6.5% at week 26
Time frame: Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in FPG at week 26.
Time frame: Week 0, week 26
Change From Baseline in Body Weight
Change from baseline in body weight at week 26.
Time frame: Week 0, week 26
Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration. Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor. Minor hypoglycaemic episodes were defined as: 1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself. 2. Any asymptomatic PG value \<3.1 mmol/L (56 mg/dL) or blood glucose value \<2.8 mmol/L (50 mg/dL). Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).
Time frame: After 26 weeks of treatment
Number of Adverse Events (AEs)
An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.
Time frame: After 26 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novo Nordisk Investigational Site
San Mateo, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Kissimmee, Florida, United States
Novo Nordisk Investigational Site
Melbourne, Florida, United States
Novo Nordisk Investigational Site
Miami, Florida, United States
...and 77 more locations