NCT01868529

Brief Summary

This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Jan 2008

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, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

May 30, 2013

Last Update Submit

September 24, 2015

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area under the glucose infusion rate curve

    0-24 hours in steady-state

Secondary Outcomes (1)

  • Area under the serum insulin concentration curve at steady state

    0-24 hours after dosing

Study Arms (3)

Low dose

EXPERIMENTAL
Drug: insulin degludecDrug: insulin glargine

Medium dose

EXPERIMENTAL
Drug: insulin degludecDrug: insulin glargine

High dose

EXPERIMENTAL
Drug: insulin degludecDrug: insulin glargine

Interventions

insulin degludecDRUG

Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.

High doseLow doseMedium dose
insulin glargineDRUG

Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.

High doseLow doseMedium dose

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months
  • Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) 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 and 28.0 kg/m\^2 (both inclusive)
  • Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
  • Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day

You may not qualify if:

  • Known or suspected allergy to trial product(s) or related products
  • Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
  • Subject who has donated any blood or plasma in the past month or in excess of 500 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 1

Interventions

insulin degludecInsulin Glargine

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 30, 2013

First Posted

June 4, 2013

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

DE(1)