This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
402
"Soft-treat-to-target" dose titration scheme, injection s.c.
"Soft-treat-to-target" dose titration scheme, injection s.c.
Unnamed facility
Salvador, Brazil
HbA1c
Time frame: For the duration of the trial
Fructosamine
Time frame: For the duration of the trial
FPG
Time frame: For the duration of the trial
4-point SMPG profiles
Time frame: For the duration of the trial
Incidence of hypoglycaemic episodes
Time frame: For the duration of the trial
Frequency and severity of adverse events (including injection site reactions)
Time frame: For the duration of the trial
Laboratory safety parameters (haematology, biochemistry and lipids)
Time frame: For the duration of the trial
Physical examination and vital signs
Time frame: For the duration of the trial
HbA1c
Time frame: For the duration of the trial
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