A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: placebo; Drug: insulin aspart; Drug: insulin degludec/insulin aspart; Drug: insulin degludec/insulin aspart 15; Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01773798

2012-004215-31 (EudraCT Number)

NN1050-4008

U1111-1134-6222 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.

Enrollment: 33 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.0-28.0 kg/m^2 (both inclusive)

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 more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking, use of nicotine substitute products or transdermal nicotine patches during the inpatient period
• Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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33 participants in 5 patient groups

IDegAsp 15

Experimental group

Treatment:

Drug: placebo

Drug: insulin degludec/insulin aspart 15

IDegAsp

Experimental group

Treatment:

Drug: placebo

Drug: insulin degludec/insulin aspart

IDeg

Experimental group

Treatment:

Drug: insulin degludec

IAsp

Active Comparator group

Treatment:

Drug: insulin aspart

IDeg + IAsp

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin aspart