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

Novo Nordisk A/S56 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 0 to 10 hours after IMP administration

Secondary Outcomes

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

Measured in pmol\*h/L

Time frame: 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

Measured in pmol\*h/L

Time frame: 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

Measured in pmol\*h/L

Time frame: 0 to 10 hours after IMP administration

Cmax,IAsp - Maximum observed serum insulin aspart concentration

Measured in pmol/L

Time frame: 0 to 10 hours after IMP administration

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

Measured in minutes

Time frame: 0 to 10 hours after IMP administration

Number of adverse events in the treatment emergent period

Count of events

Time frame: 0 to 2 days after IMP administration

Number of local reactions at the injection site in the treatment emergent period

Count of injection site reactions

Time frame: 0 to 2 days after IMP administration

Number of hypoglycaemic episodes in the treatment emergent period

Count of hypoglycaemic episodes

Time frame: 0 to 16 hours after IMP administration

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes