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

Study Overview
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Brief Summary
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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.

Official Title
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A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 at Steady State Conditions in Subjects With Type 2 Diabetes of Different Race and/or Ethnicity

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin degludec
* Drug: insulin detemir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1, first period<br> | Drug: insulin degludec<br>* 0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days<br>|
| Active Comparator: A2, second period<br> | Drug: insulin detemir<br>* 0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days<br>|
| Active Comparator: B1, first period<br> | Drug: insulin detemir<br>* 0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days<br>|
| Experimental: B2, second period<br> | Drug: insulin degludec<br>* 0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |