Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin degludec/insulin aspart 45; Drug: placebo; Drug: insulin degludec; Drug: insulin degludec/insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01868555

NN5401-1790

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp) preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar to the proposed commercial formulations.

Enrollment: 32 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese male subjects
• Body mass index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
• Body weight above or equal to 50 kg

Exclusion criteria

• The receipt of any investigational drug within 16 weeks prior to this trial (the planned first dosing)
• Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the investigator or sub-investigator
• Known or suspected allergy to trial product(s) or related products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups

IDegAsp 30

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart 30

Drug: placebo

IDegAsp 45

Experimental group

Treatment:

Drug: placebo

Drug: insulin degludec/insulin aspart 45

insulin degludec (B)

Experimental group

Treatment:

Drug: insulin degludec

Drug: placebo

insulin degludec (E)

Experimental group

Treatment:

Drug: insulin degludec

Drug: placebo