Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes
• Interventions: Drug: insulin degludec/insulin aspart; Drug: biphasic insulin aspart 30

• Registration Number: NCT00993096
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.

The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Read More

Exclusion Criteria

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
• Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDegAsp high	insulin degludec/insulin aspart	-
IDegAsp low	insulin degludec/insulin aspart	-
BIAsp 30 middle	biphasic insulin aspart 30	-
BIAsp 30 high	biphasic insulin aspart 30	-
IDegAsp middle	insulin degludec/insulin aspart	-
BIAsp 30 low	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Area (AUC) under the glucose infusion rate curve	From 0 to 24 hours after single-dose administration

Secondary Outcome Measures

Name	Time	Method
Area (AUC) under the insulin aspart concentration time curve	From 0 to 24 hours after single-dose administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany