A Phase 1 interventional study of Faster Aspart 200 U/mL and Faster aspart 100 U/mL in Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This study is looking at how five different formulations of faster aspart 200 U/mL reach and stay in the blood after injection. The purpose is to find a formulation that behaves similarly to the reference product called faster aspart 100 U/mL (marketed as Fiasp®). The participant will get all five formulations and the reference product. The order in which the participant gets them is decided by chance. The participant will get each medicine once during the study meaning that the participant will get a total of six injections with study medicine. The medicine will be injected under the skin in the stomach. The study will last for about 2 to 21 weeks depending on individual visit schedule. The participant will have nine clinic visits with the study doctor (including the one in which the participant give consent).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
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Exclusion Criteria:
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E. The dosing visits will be separated by wash-out periods (2-21 days).
Drug: Faster Aspart 200 U/mL · Drug: Faster aspart 100 U/mL
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL. The dosing visits will be separated by wash-out periods (2-21 days).
Drug: Faster Aspart 200 U/mL · Drug: Faster aspart 100 U/mL
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D. The dosing visits will be separated by wash-out periods (2-21 days).
Drug: Faster Aspart 200 U/mL · Drug: Faster aspart 100 U/mL
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B. The dosing visits will be separated by wash-out periods (2-21 days).
Drug: Faster Aspart 200 U/mL · Drug: Faster aspart 100 U/mL
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C. The dosing visits will be separated by wash-out periods (2-21 days).
Drug: Faster Aspart 200 U/mL · Drug: Faster aspart 100 U/mL
Participants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A. The dosing visits will be separated by wash-out periods (2-21 days).
Drug: Faster Aspart 200 U/mL · Drug: Faster aspart 100 U/mL
A single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.
A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure
Measured in pmol\*h/L
Time frame: 0 to 10 hours after IMP administration
AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration
Measured in pmol\*h/L
Time frame: 0 to 1 hour after IMP administration
AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration
Measured in pmol\*h/L
Time frame: 0 to 2 hours after IMP administration
AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity
Measured in pmol\*h/L
Time frame: 0 to 10 hours after IMP administration
Cmax,IAsp - Maximum observed serum insulin aspart concentration
Measured in pmol/L
Time frame: 0 to 10 hours after IMP administration
tmax,IAsp - Time to maximum observed serum insulin aspart concentration
Measured in minutes
Time frame: 0 to 10 hours after IMP administration
Number of adverse events in the treatment emergent period
Count of events
Time frame: 0 to 2 days after IMP administration
Number of local reactions at the injection site in the treatment emergent period
Count of injection site reactions
Time frame: 0 to 2 days after IMP administration
Number of hypoglycaemic episodes in the treatment emergent period
Count of hypoglycaemic episodes
Time frame: 0 to 16 hours after IMP administration
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 Mar 2020. You cannot join it, but the record below documents what was studied.
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