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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

Tracking Information
First Submitted Date  ICMJE January 5, 2018
First Posted Date  ICMJE January 23, 2018
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE January 8, 2018
Actual Primary Completion Date July 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03407599 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Cmax,IAsp, maximum observed serum insulin aspart concentration [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.
  • tmax,IAsp, time to maximum observed serum insulin aspart concentration [ Time Frame: 0-12 hours ]
    Calculated based on insulin aspart measured in blood.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Plasma glucose concentration 1 hour after administration [ Time Frame: 1 hour after administration ]
    Calculated based on glucose concentration measured in plasma.
  • Plasma glucose concentration 2 hours after administration [ Time Frame: 2 hours after administration ]
    Calculated based on glucose concentration measured in plasma.
  • Maximum plasma glucose excursion after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.
  • Maximum plasma glucose concentration after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.
  • Time to maximum plasma glucose concentration after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.
  • Minimum plasma glucose concentration after administration [ Time Frame: 0-6 hours ]
    Calculated based on glucose concentration measured in plasma.
  • Number of adverse events [ Time Frame: From screening day 1 up to the study completion day 68 ]
    Count of events
  • Number of hypoglycaemic episodes [ Time Frame: From screening day 1 up to the study completion day 68 ]
    Count of hypoglycaemic episodes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
Official Title  ICMJE A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
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®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Faster aspart
    • Drug: Insulin aspart (NovoRapid®)
  • 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.
    Interventions:
    • Drug: Faster aspart
    • Drug: Insulin aspart (NovoRapid®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2018)
46
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2018)
66
Actual Study Completion Date  ICMJE July 5, 2018
Actual Primary Completion Date July 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 64 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03407599
Other Study ID Numbers  ICMJE NN1218-4371
2017-002014-31 ( Registry Identifier: European Medicines Agency (EudraCT) )
U1111-1197-0428 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP