| Trial ID: | L4423 |
| Source ID: | NCT00676819
|
| Associated Drug: |
Insulin Aspart
|
| Title: |
Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: insulin aspart|DRUG: human insulin
|
| Outcome Measures: |
Primary: Glucose infusion rate, in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min)) | Secondary: AUCGIR(0-300 min) the area under the GIR profile, in the interval 0-300 minutes post dosing|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|AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile, in the interval 0-60 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
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
19
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-01-10
|
| Completion Date: |
2002-07-19
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| Results First Posted: |
|
| Last Update Posted: |
2017-03-16
|
| Locations: |
Novo Nordisk Investigational Site, Köln, 50825, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00676819
|
