diabetes
Conditions
Interventions
The pharmacokinetic and pharmacodynamic profile of insulin aspart will be
derived from the time-action profiles of plasma insulin and glucose,
respectively, in response to subcutaneous injection of
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18-75 years
 - Body-Mass Index >=25 kg/m2 and =48 (6.5%) and
Exclusion criteria
Exclusion criteria: - Inability to provide informed consent
 - Insulin requirement of <34 or >200 units per day
 - Treatment with systemic corticosteroids, immunosuppressive or cytostatic drugs 
 - Known allergy to aspart insulin
 - Use of oral antidiabetic drugs other than metformin 
 - Symptomatic diabetic neuropathy
 - History of a major cardiovascular disease event (myocardial infarction, stroke, symptomatic peripheral artery disease, coronary bypass surgery, percutaneous coronary or peripheral artery angioplasty) in the previous 6 months
 - Pregnancy or the intention to become pregnant
 - Renal disease (creatinine >150 µmol/l or MDRD-GFR <30 ml/min/1.73m2)
 - Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range)
 - Presence of any other medical condition that might interfere with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time in minutes until plasma glucose concentration has dropped with >=10 mmol/l. | — |
Secondary
| Measure | Time frame |
|---|---|
| The time until plasma glucose values drop below 8 and 5 mmol/l, the slope of the glucose fall, the area under the time-glucose curve from time 0 to 2h and 0 to 6h, (time to) maximal insulin concentration, total duration of hyperinsulinaemia, area under the insulin concentration curve and time until 50% of insulin absorption. | — |
Countries
Netherlands
Outcome results
None listed