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

NCT ID: NCT03723759

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-26
• Study Completion Date: 2019-03-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

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).

Group Type: EXPERIMENTAL

Faster Aspart 200 U/mL

Intervention Type: 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

Intervention Type: DRUG

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

Group B

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).

Group Type: EXPERIMENTAL

Faster Aspart 200 U/mL

Intervention Type: 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

Intervention Type: DRUG

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

Group C

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).

Group Type: EXPERIMENTAL

Faster Aspart 200 U/mL

Intervention Type: 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

Intervention Type: DRUG

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

Group D

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).

Group Type: EXPERIMENTAL

Faster Aspart 200 U/mL

Intervention Type: 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

Intervention Type: DRUG

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

Group E

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).

Group Type: EXPERIMENTAL

Faster Aspart 200 U/mL

Intervention Type: 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

Intervention Type: DRUG

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

Group F

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).

Group Type: EXPERIMENTAL

Faster Aspart 200 U/mL

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Faster Aspart 200 U/mL

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.

Intervention Type: DRUG

Faster aspart 100 U/mL

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

Other Identifiers

U1111-1209-2099

Identifier Type: OTHER

Identifier Source: secondary_id

2018-000593-30

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1200-4431

Identifier Type: -

Identifier Source: org_study_id