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The Effect of NN1250 in Subjects With Type 2 Diabetes of Different Race and/or Ethnic Origin

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: insulin detemir
Drug: insulin degludec

Study type

Interventional

Funder types

Industry

Identifiers

NCT01043510
U1111-1112-6185 (Other Identifier)
NN1250-3762

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

63 participants in 4 patient groups

A1, first period
Experimental group
Treatment:
Drug: insulin degludec
A2, second period
Active Comparator group
Treatment:
Drug: insulin detemir
B1, first period
Active Comparator group
Treatment:
Drug: insulin detemir
B2, second period
Experimental group
Treatment:
Drug: insulin degludec

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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