A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: Insulin aspart; Drug: Faster-acting insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT03215498

NN1218-4349

U1111-1189-1545 (Other Identifier)

2016-004306-34 (Registry Identifier)

Details and patient eligibility

About

The aim of the study is to compare the pharmacokinetics (i.e. the course of the blood concentrations of the administered trial drug) of faster-acting insulin aspart (faster aspart), and the currently marketed formulation of insulin aspart (NovoRapid®) when given as a bolus using an insulin pump in people with type 1 diabetes. The pharmacodynamic response (i.e. the course of the blood sugar lowering effect of the administered trial drug) and the safety and tolerability of faster aspart and NovoRapid® will also be assessed.

The participants will be in the study for approx. 21 days. Each participant will have 5 visits to the clinic, with an overnight stay at both dosing visits. Participants will have a number of tests, and they will have to give blood and urine samples.

Enrollment: 58 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18 - 64 years (both inclusive) at the time of signing informed consent.
• Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer.
• Body mass index 18.5 - 28.0 kg/sqm (both inclusive).
• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups

Faster aspart followed by insulin aspart

Experimental group

Description:

Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery

Treatment:

Drug: Faster-acting insulin aspart

Drug: Insulin aspart

Insulin aspart followed by faster aspart

Experimental group

Description:

Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery

Treatment:

Drug: Faster-acting insulin aspart

Drug: Insulin aspart