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

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