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Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
insulin degludec
insulin degludec/insulin aspart
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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).
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

IDeg

IDegAsp

IAsp

Arm Description

Outcomes

Primary Outcome Measures

Area under the glucose infusion rate curve
Area under the glucose infusion rate curve

Secondary Outcome Measures

Area under the insulin degludec concentration-time curve
Maximum observed insulin degludec concentration
Area under the insulin aspart concentration-time curve
Maximum observed insulin aspart concentration

Full Information

First Posted
October 8, 2009
Last Updated
November 26, 2013
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00992537
Brief Title
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics
Official Title
A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDeg
Arm Type
Experimental
Arm Title
IDegAsp
Arm Type
Experimental
Arm Title
IAsp
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin degludec/insulin aspart
Intervention Description
Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate curve
Time Frame
From 0 to 6 hours after single-dose administration
Title
Area under the glucose infusion rate curve
Time Frame
From 4 to 24 hours after single-dose administration
Secondary Outcome Measure Information:
Title
Area under the insulin degludec concentration-time curve
Time Frame
From 0 to 120 hours after single-dose administration
Title
Maximum observed insulin degludec concentration
Time Frame
From 0 to 120 hours after single-dose administration
Title
Area under the insulin aspart concentration-time curve
Time Frame
From 0 to 12 hours after single-dose administration
Title
Maximum observed insulin aspart concentration
Time Frame
0-12 hours after single-dose administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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). Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics

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