Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.
Interventions
DRUGinsulin detemir
DRUGinsulin aspart
DEVICEbiphasic insulin aspart
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 * Duration of type 2 diabetes for at least 6 months since diagnosis * Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily * BMI below 40 kg/m2 * HbA1c between 7-12% * Able and willing to perform self-monitoring of capillary blood glucose
Exclusion criteria
* Current antidiabetic treatment with combination of three or more oral antidiabetic drugs * Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed) * Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator * Known or suspected allergy to trial product or related products * Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures * Receipt of any investigational drug within 4 weeks prior to this trial * Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | after 6 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of hypoglycaemic episodes | — |
| Adverse events | — |
| Difference of HbA1c change between the two groups | after 13 weeks of treatment |
| Fasting plasma glucose of treatment | after 13 and 26 weeks |
| Change in weight | — |
Countries
Austria, Germany, Switzerland
Outcome results
None listed