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A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03407599
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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®.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: Faster aspart Drug: Insulin aspart (NovoRapid®) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 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 masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : July 5, 2018
Actual Study Completion Date : July 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Faster aspart followed by insulin aspart (NovoRapid®)
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
An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.

Drug: Insulin aspart (NovoRapid®)
An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.

Experimental: Insulin aspart (NovoRapid®) followed by faster aspart
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
An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.

Drug: Insulin aspart (NovoRapid®)
An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.




Primary Outcome Measures :
  1. AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.


Secondary Outcome Measures :
  1. AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes [ Time Frame: 0-15 minutes ]
    Calculated based on insulin aspart measured in blood.

  2. AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes [ Time Frame: 0-30 minutes ]
    Calculated based on insulin aspart measured in blood.

  3. AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour [ Time Frame: 0-1 hour ]
    Calculated based on insulin aspart measured in blood.

  4. AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour [ Time Frame: 0-1½ hour ]
    Calculated based on insulin aspart measured in blood.

  5. AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours [ Time Frame: 0-2 hours ]
    Calculated based on insulin aspart measured in blood.

  6. Cmax,IAsp, maximum observed serum insulin aspart concentration [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.

  7. tmax,IAsp, time to maximum observed serum insulin aspart concentration [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.

  8. 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) [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.

  9. 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 [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.

  10. Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.

  11. Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.

  12. Mean change in plasma glucose concentration from 0-1 hour after administration [ Time Frame: 0-1 hour ]
    Calculated based on glucose concentration measured in plasma.

  13. Mean change in plasma glucose concentration from 0-2 hours after administration [ Time Frame: 0-2 hours ]
    Calculated based on glucose concentration measured in plasma.

  14. Mean change in plasma glucose concentration from 0-6 hours after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.

  15. Change from baseline in plasma glucose concentration 1 hour after administration [ Time Frame: Pre-dose (0 hour), 1 hour ]
    Calculated based on glucose concentration measured in plasma.

  16. Change from baseline in plasma glucose concentration 2 hours after administration [ Time Frame: Pre-dose (0 hour), 2 hours ]
    Calculated based on glucose concentration measured in plasma.

  17. Plasma glucose concentration 1 hour after administration [ Time Frame: 1 hour after administration ]
    Calculated based on glucose concentration measured in plasma.

  18. Plasma glucose concentration 2 hours after administration [ Time Frame: 2 hours after administration ]
    Calculated based on glucose concentration measured in plasma.

  19. Maximum plasma glucose excursion after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.

  20. Maximum plasma glucose concentration after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.

  21. Time to maximum plasma glucose concentration after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.

  22. Minimum plasma glucose concentration after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.

  23. Number of adverse events [ Time Frame: From screening day 1 up to the study completion day 68 ]
    Count of events

  24. Number of hypoglycaemic episodes [ Time Frame: From screening day 1 up to the study completion day 68 ]
    Count of hypoglycaemic episodes



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Ages Eligible for Study:   6 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
  • Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening
  • Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm

Exclusion Criteria:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

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): NCT03407599


Locations
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Germany
Novo Nordisk Investigational Site
Hannover, Germany, 30173
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: NCT03407599     History of Changes
Other Study ID Numbers: NN1218-4371
2017-002014-31 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1197-0428 ( Other Identifier: World Health Organization (WHO) )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 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, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs