Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes for at least 12 months * Stable glycaemic control, having been on the existing treatment for at least 1 month * BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese) * HbA1c below 9.0% * Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly
Exclusion criteria
* A history of drug abuse or alcohol dependence * Blood donation within the last 3 months * Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose * Severe, uncontrolled hypertension * Proliferative retinopathy or maculopathy requiring acute treatment * Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum glucose concentration profile during 24 hours | after 4 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics properties | — |
| Pharmacokinetic properties | — |
| 8-point self-monitored blood glucose profiles | — |
| Adverse events | — |
| Hypoglycaemic episodes | — |
Countries
Denmark
Outcome results
None listed