This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Novo Nordisk Investigational Site
Camperdown, New South Wales, Australia
Novo Nordisk Investigational Site
Ashford, Australia
Novo Nordisk Investigational Site
Box Hill, Australia
Incidence of total self-recorded hypoglycaemic episodes
Incidence of total major hypoglycaemic episodes
HbA1c (glycosylated haemoglobin)
8-point plasma glucose profiles
Serum glucose profiles
72-hours glucose profile
Within-subject variation in home-measured fasting plasma glucose
Incidence of adverse events
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Novo Nordisk Investigational Site
Zagreb, Croatia
Novo Nordisk Investigational Site
Århus C, Denmark
Novo Nordisk Investigational Site
Køge, Denmark
Novo Nordisk Investigational Site
Città di Castello, Italy
Novo Nordisk Investigational Site
Perugia, Italy
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa
Novo Nordisk Investigational Site
Linköping, Sweden
...and 1 more locations