NCT01865292

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Aug 2006

Shorter than P25 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

August 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
6.6 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 19, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

May 27, 2013

Last Update Submit

October 16, 2015

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Area under the glucose infusion rate curve

    0-24 hours after dosing

Secondary Outcomes (1)

  • Area under the insulin degludec/insulin glargine curve

    0-96 hours after dosing

Study Arms (2)

Insulin degludec

EXPERIMENTAL
Drug: insulin degludec

Insulin glargine

ACTIVE COMPARATOR
Drug: insulin glargine

Interventions

insulin degludecDRUG

Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

Insulin degludec
insulin glargineDRUG

Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.

Insulin glargine

Eligibility Criteria

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

You may qualify if:

  • Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
  • Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
  • Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
  • Treated with insulin for the past 3 months prior to screening
  • Body Mass Index (BMI) between 22.0 and 35.0 kg/ m\^2 (both inclusive)

You may not qualify if:

  • Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
  • Subject with a history of or presence of cancer
  • Any condition that the Investigator and/or Sponsor feels would interfere with study
  • Therapy with oral antidiabetic drugs within the past 3 months prior to 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 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 27, 2013

First Posted

May 30, 2013

Study Start

August 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

DE(1)