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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00992537

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: insulin degludec Drug: insulin degludec/insulin aspart Drug: insulin aspart	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IDeg	Drug: insulin degludec Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Experimental: IDegAsp	Drug: insulin degludec/insulin aspart Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Active Comparator: IAsp	Drug: insulin aspart Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

Arm

Intervention/Treatment

Experimental: IDeg

Drug: insulin degludec

Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

Experimental: IDegAsp

Drug: insulin degludec/insulin aspart

Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

Active Comparator: IAsp

Drug: insulin aspart

Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

Outcome Measures

Primary Outcome Measures

Area under the glucose infusion rate curve [From 0 to 6 hours after single-dose administration]
Area under the glucose infusion rate curve [From 4 to 24 hours after single-dose administration]

Secondary Outcome Measures

Area under the insulin degludec concentration-time curve [From 0 to 120 hours after single-dose administration]
Maximum observed insulin degludec concentration [From 0 to 120 hours after single-dose administration]
Area under the insulin aspart concentration-time curve [From 0 to 12 hours after single-dose administration]
Maximum observed insulin aspart concentration [0-12 hours after single-dose administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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