A Randomised, Double-blind, Single Centre, Placebocontrolled, Parallel Group, Multiple s.c. Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Two SIAC Preparations and Two Insulin 454 (SIBA) Preparations in Healthy Japanese Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 32
- Primary Endpoint
- Adverse events (AEs)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
insulin degludec (E)
Intervention: insulin degludec (Drug)
insulin degludec (E)
Intervention: placebo (Drug)
IDegAsp 30
Intervention: insulin degludec/insulin aspart 30 (Drug)
IDegAsp 30
Intervention: placebo (Drug)
IDegAsp 45
Intervention: insulin degludec/insulin aspart 45 (Drug)
IDegAsp 45
Intervention: placebo (Drug)
insulin degludec (B)
Intervention: insulin degludec (Drug)
insulin degludec (B)
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Adverse events (AEs)
Time Frame: Day 1-6 and 7-28 days after day 6
Secondary Outcomes
- Area under the serum insulin 454 concentration curve(0-96 hours after last dosing)
- Area under the serum insulin aspart concentration curve(0-6 hours after dosing)