Diabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGinsulin degludec
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
DRUGinsulin detemir
0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve during one dosing interval at steady state | 0-24 hours (derived on treatment day 6) |
Secondary
| Measure | Time frame |
|---|---|
| Area under the Insulin Degludec concentration-time curve during one dosing interval at steady state | 0-24 hours (derived on treatment day 6) |
Countries
United States
Outcome results
None listed