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

NCT03407599 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN1218-43712017-002014-31U1111-1197-0428
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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®.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours

  Calculated based on insulin aspart measured in blood.

  0-12 hours

Secondary Outcomes (24)

• AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes

  0-15 minutes

• AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes

  0-30 minutes

• AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour

  0-1 hour

• AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour

  0-1½ hour

• AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours

  0-2 hours

Study Arms (2)

Faster aspart followed by insulin aspart (NovoRapid®)

EXPERIMENTAL

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; Drug: Insulin aspart (NovoRapid®)

Insulin aspart (NovoRapid®) followed by faster aspart

EXPERIMENTAL

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; Drug: Insulin aspart (NovoRapid®)

Interventions

Faster aspart DRUG

An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.

Faster aspart followed by insulin aspart (NovoRapid®); Insulin aspart (NovoRapid®) followed by faster aspart

Insulin aspart (NovoRapid®) DRUG

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

Faster aspart followed by insulin aspart (NovoRapid®); Insulin aspart (NovoRapid®) followed by faster aspart

Eligibility Criteria

• Age: 6 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Hanover, 30173, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 23, 2018
• Study Start: January 8, 2018
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)