A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01618188

Collaborator

(none)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

Actual Study Start Date :

Jun 11, 2012

Actual Primary Completion Date :

Sep 7, 2012

Actual Study Completion Date :

Sep 7, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Formulation A	Drug: Faster-acting insulin aspart A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration. Other Names: NN1218
Experimental: Formulation B	Drug: Faster-acting insulin aspart A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration. Other Names: NN1218
Active Comparator: Insulin Aspart	Drug: insulin aspart A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.

Arm

Intervention/Treatment

Experimental: Formulation A

Drug: Faster-acting insulin aspart

A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.

Other Names:

NN1218

Experimental: Formulation B

Drug: Faster-acting insulin aspart

A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.

Other Names:

NN1218

Active Comparator: Insulin Aspart

Drug: insulin aspart

A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.

Outcome Measures

Primary Outcome Measures

Area under the glucose infusion rate curve [From 0 to 2 hours]

Secondary Outcome Measures

Area under the glucose infusion rate curve [From 0 to 12 hours]
Maximum glucose infusion rate [Within 0 to 12 hours after dosing]
Time to maximum glucose infusion rate [Within 0 to 12 hours after dosing]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 1 diabetes mellitus for more than 12 months
Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months
Body mass index (BMI) between 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 trial start
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 substitute products during the inpatient period