A Phase 1 interventional study of insulin aspart and human regular insulin in Diabetes Mellitus, sponsored by Profil Institut für Stoffwechselforschung GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-08-09.
Sponsored by Profil Institut für Stoffwechselforschung GmbH · Phase 1, Interventional, and Treatment
The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.
Double-blind, randomized, 6-period cross-over study in 16 healthy subjects. Each patient participates in 6 euglycemic glucose clamp experiments each.
The time interval between the study days is 2 to 28 days. At the clamp visits, subjects are connected to a Biostator (MTB Medizintechnik, Ulm, Germany) and receive an intravenous human insulin infusion (rate of 0.15 mU/kg/min) over the duration of each experiment to prevent a rise in endogenous insulin secretion. After a baseline period of 2 h the trial drug (6, 12, or 24 U of either Insulin Aspart or regular human insulin in random order) are administered s.c. with a syringe into the abdominal wall. Glucose infusion rates (GIR) necessary to keep blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered and recorded by the Biostator every minute for a period of 12 h post-dosing. Blood samples are drawn at regular intervals for the analysis of C-peptide and (depending on the trial drug administered) serum insulin or serum Insulin Aspart concentrations (measured with specific ELISAs).
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 16 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Profil Institut für Stoffwechselforschung GmbH is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 U insulin aspart
Drug: insulin aspart
12 U insulin aspart
Drug: insulin aspart
24 U insulin aspart
Drug: insulin aspart
6 IU human regular insulin
Drug: human regular insulin
12 IU human regular insulin
Drug: human regular insulin
24 IU human regular insulin
Drug: human regular insulin
6, 12, 24 U s.c.
Also known as: Novorapid
6, 12 and 24 IU sc
Also known as: Actrapid
AUC GIR 360-720 min
Time frame: at each dosing (6 times during the trial)
PK endpoints such as C max/ins, t max/ins, AUC ins 0-120 min, AUC ins 360-720 min, AUC ins 0-720 min
Time frame: at each dosing visit (6 times during the study)
PD endpoints like GIR max, t max/GIR, AUC GIR 0-120 min, AUC GIR 0-720 min, t >2/GIR, early and late t 50%/GIR
Time frame: at each dosing visit (6 times during the study)
This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Profil Institut für Stoffwechselforschung GmbH