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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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