This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
493
Injected subcutaneously (under the skin) once daily
Insulin glargine injected subcutaneously (under the skin) once daily
At least three daily doses at meal-time
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Change from baseline in HbA1c after 26 weeks of treatment
Time frame: Week 0, Week 26
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time frame: Week 0 to Week 52 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Time frame: Week 0 to Week 52 + 7 days follow up
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks of treatment.
Time frame: Week 0, Week 52
Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment
Change from baseline in FPG after 26 weeks of treatment
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Novo Nordisk Investigational Site
Encino, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
Huntington Beach, California, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Novo Nordisk Investigational Site
Redondo Beach, California, United States
Novo Nordisk Investigational Site
Walnut Creek, California, United States
Novo Nordisk Investigational Site
Aurora, Colorado, United States
Novo Nordisk Investigational Site
Denver, Colorado, United States
Novo Nordisk Investigational Site
DeLand, Florida, United States
Novo Nordisk Investigational Site
Hollywood, Florida, United States
...and 72 more locations
Time frame: Week 0, Week 26
Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Change from baseline in FPG after 52 weeks of treatment.
Time frame: Week 0, Week 52