Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.
Interventions
DRUGEX1000
Treat-to-target titration scheme, s.c. injection
Treat-to-target titration scheme, s.c. injection
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 biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs * Body Mass Index (BMI) less than or equal to 40.0 kg/m2 * HbA1c less than or equal to 9.5% * FPG (SMPG) less than or equal to 12 mmol/L
Exclusion criteria
* Treatment with more than 1IU/kg insulin daily * Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors * 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 | after 8 weeks of treatment |
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 |
| Incidence of hypoglycaemic episodes | For the duration of the trial |
| HbA1c | For the duration of the trial |
| Laboratory safety parameters (haematology, biochemistry and lipids) | For the duration of the trial |
| Physical examination and vital signs | For the duration of the trial |
| Total daily insulin dosages | For the duration of the trial |
| Frequency and severity of adverse events (including injection site reactions) | For the duration of the trial |
Countries
India, South Africa, United Arab Emirates
Outcome results
None listed