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

NCT03723759 | Completed Phase 1 FDA Drug

• 3 other identifiers: NN1200-4431U1111-1209-20992018-000593-30
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

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

  Measured in pmol\*h/L

  0 to 10 hours after IMP administration

Secondary Outcomes (8)

• AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration

  0 to 1 hour after IMP administration

• AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration

  0 to 2 hours after IMP administration

• AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity

  0 to 10 hours after IMP administration

• Cmax,IAsp - Maximum observed serum insulin aspart concentration

  0 to 10 hours after IMP administration

• tmax,IAsp - Time to maximum observed serum insulin aspart concentration

  0 to 10 hours after IMP administration

Study Arms (6)

Group A

EXPERIMENTAL

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; Drug: Faster aspart 100 U/mL

Group B

EXPERIMENTAL

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; Drug: Faster aspart 100 U/mL

Group C

EXPERIMENTAL

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; Drug: Faster aspart 100 U/mL

Group D

EXPERIMENTAL

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; Drug: Faster aspart 100 U/mL

Group E

EXPERIMENTAL

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; Drug: Faster aspart 100 U/mL

Group F

EXPERIMENTAL

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; Drug: Faster aspart 100 U/mL

Interventions

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.

Group A; Group B; Group C; Group D; Group E; Group F

Faster aspart 100 U/mL DRUG

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

Group A; Group B; Group C; Group D; Group E; Group F

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

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 asked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: October 26, 2018
• Primary Completion: March 21, 2019
• Study Completion: March 27, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)