NCT01043510

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or ethnicity.

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 2010

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, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

January 5, 2010

Last Update Submit

January 20, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

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 day 6)

Secondary Outcomes (1)

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

    0-24 hours (derived on treatment day 6)

Study Arms (4)

A1, first period

EXPERIMENTAL
Drug: insulin degludec

A2, second period

ACTIVE COMPARATOR
Drug: insulin detemir

B1, first period

ACTIVE COMPARATOR
Drug: insulin detemir

B2, second period

EXPERIMENTAL
Drug: insulin degludec

Interventions

insulin degludecDRUG

0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days

A1, first periodB2, second period
insulin detemirDRUG

0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days

A2, second periodB1, first period

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Either - Black or African American not of Hispanic or Latino origin or - White of Hispanic or Latino origin or - White not of Hispanic or Latino origin
  • Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Treated with insulin for at least 3 months, alone or in combination with maximum 2 oral antidiabetic drugs (OADs)
  • Body mass index maximum 40.0 kg/m\^2

You may not qualify if:

  • Use of GLP-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to screening
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Chula Vista, California, 91911, United States

Location

Related Publications (2)

  • Hompesch M, Morrow L, Watkins E, Roepstorff C, Thomsen HF, Haahr H. Pharmacokinetic and pharmacodynamic responses of insulin degludec in African American, white, and Hispanic/Latino patients with type 2 diabetes mellitus. Clin Ther. 2014 Apr 1;36(4):507-15. doi: 10.1016/j.clinthera.2013.12.014. Epub 2014 Feb 5.

    PMID: 24508419RESULT

  • 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

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin degludecInsulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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

January 5, 2010

First Posted

January 6, 2010

Study Start

January 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

US(1)