NCT00961324

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) 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
54

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Jul 2009

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

July 27, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2009

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

August 17, 2009

Last Update Submit

October 6, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area under the glucose infusion rate curve during one dosing interval at steady state

    0-24 hours (derived on treatment days 6, 9 and 12)

Secondary Outcomes (1)

  • Area under the NN1250 concentration-time curve during one dosing interval at steady state

    0-24 hours (derived on treatment days 6, 9 and 12)

Study Arms (2)

IDeg

EXPERIMENTAL
Drug: insulin degludec

IGlar

EXPERIMENTAL
Drug: insulin glargine

Interventions

insulin degludecDRUG

The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days

IDeg
insulin glargineDRUG

The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days

IGlar

Eligibility Criteria

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

You may qualify if:

  • Male or female aged 18-65 years (both inclusive)
  • 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 and use of nicotine gum or transdermal nicotine patches during the inpatient period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (3)

  • Heise T, Hermanski L, Nosek L, Feldman A, Rasmussen S, Haahr H. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012 Sep;14(9):859-64. doi: 10.1111/j.1463-1326.2012.01627.x. Epub 2012 Jun 7.

    PMID: 22594461RESULT

  • Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24.

    PMID: 25581159RESULT

  • Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2018 Mar;12(2):356-363. doi: 10.1177/1932296817731422. Epub 2017 Sep 26.

    PMID: 28946756RESULT

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2009

First Posted

August 18, 2009

Study Start

July 27, 2009

Primary Completion

October 26, 2009

Study Completion

October 26, 2009

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations

DE(1)