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

NCT01868555 | Completed Phase 1

• 1 other identifier: NN5401-1790
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Day 1-6 and 7-28 days after day 6

Secondary Outcomes (2)

• 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

Study Arms (4)

IDegAsp 30

EXPERIMENTAL

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

IDegAsp 45

EXPERIMENTAL

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

insulin degludec (B)

EXPERIMENTAL

Drug: insulin degludec; Drug: placebo

insulin degludec (E)

EXPERIMENTAL

Drug: insulin degludec; Drug: placebo

Interventions

insulin degludec DRUG

Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

insulin degludec (B); insulin degludec (E)

insulin degludec/insulin aspart 30 DRUG

Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

IDegAsp 30

insulin degludec/insulin aspart 45 DRUG

Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

IDegAsp 45

placebo DRUG

Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days

IDegAsp 30; IDegAsp 45; insulin degludec (B); insulin degludec (E)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Tokyo, 1000005, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: December 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

JP (1)