NCT01865279

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commerical formulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

May 27, 2013

Last Update Submit

October 22, 2015

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Frequency of adverse events (trial part 1 only)

    From day prior to dosing and until 10-14 days after dosing

  • Area under the glucose infusion rate curve (trial part 2 only)

    0-24 hours after dosing

Secondary Outcomes (1)

  • Area under the serum insulin concentration curve

    0-72 hours after dosing

Study Arms (2)

Trial part 1

EXPERIMENTAL
Drug: insulin degludecDrug: placebo

Trial part 2

ACTIVE COMPARATOR
Drug: insulin degludecDrug: isophane human insulin

Interventions

insulin degludecDRUG

Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data.

Trial part 1
placeboDRUG

Ascending single doses - 5 dose levels

Trial part 1
isophane human insulinDRUG

A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes

Trial part 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HEALTHY SUBJECTS:
  • Subjects will be healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Body mass index (BMI) between 18.0-27.0 kg/m\^2 (both inclusive)
  • SUBJECTS WITH TYPE 1 AND TYPE 2 DIABETES:
  • Subjects will be male volunteers, who are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months or diagnosed with type 2 diabetes mellitus for at least 12 months
  • Body Mass Index (BMI) between 18.0-27.0 kg/m\^2 (both inclusive) for subjects with type 1 diabetes or 25.0-35.0 kg/m\^2 (both inclusive) for subjects with type 2 diabetes
  • Glycogylated haemoglobin (HbA1c) maximum 8.5 % based on central laboratory results
  • Subjects with type 2 diabetes must have been treated with insulin for the past 3 months prior to screening

You may not qualify if:

  • Participation in any other trials involving investigational products within 3 months preceding the start of dosing
  • History of significant multiple drug allergies or with a known allergy to the trial product or any medicine chemically related to the trial product, as judged by the investigator
  • Hepatitis or carrier of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies or a positive result to the test for human immunodeficiency (HIV) antibodies
  • Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the investigator
  • Subjects who have donated any blood or plasma in the past month or in excess of 1000 ml within the 12 weeks preceding screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

insulin degludecInsulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2013

First Posted

May 30, 2013

Study Start

December 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

DE(1)