NCT01773798

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Jan 2013

Typical duration for phase_1 diabetes

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

January 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

January 18, 2013

Last Update Submit

March 4, 2015

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area under the glucose infusion rate curve

    From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp)

Secondary Outcomes (2)

  • Area under the serum IDeg concentration-time curve

    From 0 to 120 hours after single dose

  • Area under the serum IAsp concentration-time curve

    From 0 to 12 hours after single dose

Study Arms (5)

IDegAsp 15

EXPERIMENTAL
Drug: insulin degludec/insulin aspart 15Drug: placebo

IDegAsp

EXPERIMENTAL
Drug: insulin degludec/insulin aspartDrug: placebo

IDeg

EXPERIMENTAL
Drug: insulin degludec

IAsp

ACTIVE COMPARATOR
Drug: insulin aspart

IDeg + IAsp

EXPERIMENTAL
Drug: insulin degludecDrug: insulin aspart

Interventions

insulin degludec/insulin aspart 15DRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).

IDegAsp 15
insulin degludec/insulin aspartDRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).

Also known as: IDegAsp
IDegAsp
insulin degludecDRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).

IDegIDeg + IAsp
insulin aspartDRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).

IAspIDeg + IAsp
placeboDRUG

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.

IDegAspIDegAsp 15

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

You may not qualify if:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking, use of nicotine substitute products or transdermal nicotine patches during the inpatient period
  • Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Graz, 8010, Austria

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

insulin degludecinsulin degludec, insulin aspart drug combinationInsulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-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

January 18, 2013

First Posted

January 23, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

AU(1)