A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03723759
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 6
• Actual Duration (Months): 5
• Patients Per Site Per Month: 11.2

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: Faster Aspart 200 U/mL; Drug: Faster aspart 100 U/mL	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Sponsor staff involved in the clinical trial is asked according to company standard procedures
• Primary Purpose: Treatment
• Official Title: A Trial Investigating the Pharmacokinetic Properties of Five Formulations of Fast-acting Insulin Aspart 200 U/mL in Subjects With Type 1 Diabetes Mellitus
• Actual Study Start Date: Oct 26, 2018
• Actual Primary Completion Date: Mar 21, 2019
• Actual Study Completion Date: Mar 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A 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; 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.; Drug: Faster aspart 100 U/mL; A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
Experimental: Group B 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; 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.; Drug: Faster aspart 100 U/mL; A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
Experimental: Group C 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; 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.; Drug: Faster aspart 100 U/mL; A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
Experimental: Group D 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; 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.; Drug: Faster aspart 100 U/mL; A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
Experimental: Group E 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; 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.; Drug: Faster aspart 100 U/mL; A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
Experimental: Group F 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; 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.; Drug: Faster aspart 100 U/mL; A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.

Outcome Measures

Primary Outcome Measures

1. 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 [0 to 10 hours after IMP administration]

   Measured in pmol*h/L

Secondary Outcome Measures

1. AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration [0 to 1 hour after IMP administration]

   Measured in pmol*h/L

2. AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration [0 to 2 hours after IMP administration]

   Measured in pmol*h/L

3. AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity [0 to 10 hours after IMP administration]

   Measured in pmol*h/L

4. Cmax,IAsp - Maximum observed serum insulin aspart concentration [0 to 10 hours after IMP administration]

   Measured in pmol/L

5. tmax,IAsp - Time to maximum observed serum insulin aspart concentration [0 to 10 hours after IMP administration]

   Measured in minutes

6. Number of adverse events in the treatment emergent period [0 to 2 days after IMP administration]

   Count of events

7. Number of local reactions at the injection site in the treatment emergent period [0 to 2 days after IMP administration]

   Count of injection site reactions

8. Number of hypoglycaemic episodes in the treatment emergent period [0 to 16 hours after IMP administration]

   Count of hypoglycaemic episodes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent

• Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening

• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion greater than or equal to 1 year prior to the day of screening

Exclusion Criteria:

• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening in this trial

• Blood donation, plasma donation or blood draw, defined as any of the below: In excess of 400 mL within the past 90 days prior to the day of screening OR In excess of 50 mL within the past 30 days prior to the day of screening

• Use of tobacco and nicotine products, defined as any of the below: Smoking more than 1 cigarette or the equivalent per day OR Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house periods

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Neuss		Germany	41460

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03723759
• Other Study ID Numbers: NN1200-4431; U1111-1209-2099; 2018-000593-30
• First Posted: Oct 30, 2018
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination

Study Results

No Results Posted as of Mar 18, 2020