A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin degludec; Drug: insulin degludec/insulin aspart

• Registration Number: NCT01590836
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-03
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
• Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive)
• Glycosylated haemoglobin (HbA1c) maximum 9.5 %
• Fasting C-peptide maximum 0.3 nmol/L

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Exclusion Criteria

• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking, use of nicotine gum or transdermal nicotine patches during the inpatient period
• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IDeg-->IDegAsp	insulin degludec/insulin aspart	-
IDeg-->IDegAsp	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)

Secondary Outcome Measures

Name	Time	Method
Maximum glucose infusion rate (GIRmax)	At steady state (within 0-24 hours after last dosing)
Maximum observed serum insulin degludec concentration	At steady state (within 0-24 hours after last dosing)
Area under the serum insulin degludec concentration-time curve during one dosing interval	At steady state (within 0-24 hours after last dosing)
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours
Maximum observed serum insulin aspart concentration	Within 0-12 hours after dosing of IDegAsp

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany