A Phase 1 interventional study of Faster aspart and Insulin aspart (NovoRapid®) in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 6 Years to 64 Years. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children [6-11 years], adolescents [12-17 years] and adults [18-64 years]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.
Exclusion Criteria:
Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
Drug: Faster aspart · Drug: Insulin aspart (NovoRapid®)
Participants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
Drug: Faster aspart · Drug: Insulin aspart (NovoRapid®)
An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.
An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
Calculated based on insulin aspart measured in blood.
Time frame: 0-12 hours
AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes
Calculated based on insulin aspart measured in blood.
Time frame: 0-15 minutes
AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes
Calculated based on insulin aspart measured in blood.
Time frame: 0-30 minutes
AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour
Calculated based on insulin aspart measured in blood.
Time frame: 0-1 hour
AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour
Calculated based on insulin aspart measured in blood.
Time frame: 0-1½ hour
AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours
Calculated based on insulin aspart measured in blood.
Time frame: 0-2 hours
Cmax,IAsp, maximum observed serum insulin aspart concentration
Calculated based on insulin aspart measured in blood.
Time frame: 0-12 hours
tmax,IAsp, time to maximum observed serum insulin aspart concentration
Calculated based on insulin aspart measured in blood.
Time frame: 0-12 hours
Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ)
Calculated based on insulin aspart measured in blood.
Time frame: 0-12 hours
Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve
Calculated based on insulin aspart measured in blood.
Time frame: 0-12 hours
Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Calculated based on insulin aspart measured in blood.
Time frame: 0-12 hours
Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp
Calculated based on insulin aspart measured in blood.
Time frame: 0-12 hours
Mean change in plasma glucose concentration from 0-1 hour after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 0-1 hour
Mean change in plasma glucose concentration from 0-2 hours after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 0-2 hours
Mean change in plasma glucose concentration from 0-6 hours after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 0-6 hours
Change from baseline in plasma glucose concentration 1 hour after administration
Calculated based on glucose concentration measured in plasma.
Time frame: Pre-dose (0 hour), 1 hour
Change from baseline in plasma glucose concentration 2 hours after administration
Calculated based on glucose concentration measured in plasma.
Time frame: Pre-dose (0 hour), 2 hours
Plasma glucose concentration 1 hour after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 1 hour after administration
Plasma glucose concentration 2 hours after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 2 hours after administration
Maximum plasma glucose excursion after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 0-6 hours
Maximum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 0-6 hours
Time to maximum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 0-6 hours
Minimum plasma glucose concentration after administration
Calculated based on glucose concentration measured in plasma.
Time frame: 0-6 hours
Number of adverse events
Count of events
Time frame: From screening day 1 up to the study completion day 68
Number of hypoglycaemic episodes
Count of hypoglycaemic episodes
Time frame: From screening day 1 up to the study completion day 68
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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