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Completed

NCT Number: NCT03723759

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

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).

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faster Aspart 200 U/mL

Drug

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.

Faster aspart 100 U/mL

Drug

A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2018
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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