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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03723759
Recruitment Status : Completed
First Posted : October 30, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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Study Type : Interventional  (Clinical Trial)
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 : October 26, 2018
Actual Primary Completion Date : March 21, 2019
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0 to 10 hours after IMP administration ]
    Measured in pmol*h/L

  4. Cmax,IAsp - Maximum observed serum insulin aspart concentration [ Time Frame: 0 to 10 hours after IMP administration ]
    Measured in pmol/L

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

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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723759


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03723759     History of Changes
Other Study ID Numbers: NN1200-4431
U1111-1209-2099 ( Other Identifier: World Health Organization (WHO) )
2018-000593-30 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs