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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec; Drug: insulin detemir

• Registration Number: NCT01043510
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A1, first period	insulin degludec	-
B1, first period	insulin detemir	-
A2, second period	insulin detemir	-
B2, second period	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Area under the Insulin Degludec concentration-time curve during one dosing interval at steady state	0-24 hours (derived on treatment day 6)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Chula Vista, California, United States