Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes.
Interventions
DRUGinsulin aspart
DRUGhuman insulin
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Duration of diabetes for at least 12 months * Current treatment with human insulin or insulin analogues for at least 6 months * BMI equal to or below 35 kg/m2 * HbA1c equal to or greater than 10.0 % * No clinically significant cardiovascular event as judged by the Investigator within the last 6 months prior to the study
Exclusion criteria
* History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject * Current treatment with systemic corticosteroids * Any positive reaction of drug of abuse or alcohol screen * Cardiac problems defined as: decompensated heart failure and/or angina pectoris * Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure \> 180 mm Hg systolic and/or \> 110 mm Hg diastolic * Known or suspected allergy to trial product or related products * Blood donation of more than 500 ml within the last 12 weeks * The receipt of any investigational drug within 4 weeks prior to this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose infusion rate | in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min)) |
Secondary
| Measure | Time frame |
|---|---|
| AUCGIR(0 min-end of clamp) the area under the GIR profile | in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values) |
| AUCGIR(300min-end of clamp) the area under the GIR profile | in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values) |
| GIRmax: the maximal GIR value | tmax, GIR: the time to maximal GIR value |
| early and late t50%, GIR | the time to early and late half-maximal GIR value |
| AUCGIR(0-300 min) the area under the GIR profile | in the interval 0-300 minutes post dosing |
| AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile | in the interval 0-300 minutes post dosing |
| AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile | in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values) |
| AUCINS(300min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile | in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values) |
| Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration | — |
| AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile | in the interval 0-60 minutes post dosing |
Countries
Germany
Outcome results
None listed