Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGinsulin NPH
Soft-treat-to-target dose titration scheme, injection s.c.
DRUGEX1000
Soft-treat-to-target dose titration scheme, injection s.c.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes for at least 12 months * Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs * Body Mass Index (BMI) less than or equal to 40 kg/m2 * HbA1c less than or equal to 9.5% * FPG less than or equal to 12 mmol/L
Exclusion criteria
* Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors * Treatment with more than 1 IU/kg NPH insulin daily * Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator * Known or suspected allergy to trial products or related products * Receipt of any investigational drug within one month prior to this trial * Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | For the duration of the trial |
Secondary
| Measure | Time frame |
|---|---|
| Fructosamine | For the duration of the trial |
| FPG | For the duration of the trial |
| 4-point SMPG profiles | For the duration of the trial |
| Laboratory safety parameters (haematology, biochemistry and lipids) | For the duration of the trial |
| Frequency and severity of adverse events (including injection site reactions) | For the duration of the trial |
| Physical examination and vital signs | For the duration of the trial |
| HbA1c | For the duration of the trial |
| Incidence of hypoglycaemic episodes | For the duration of the trial |
Countries
Brazil
Outcome results
None listed